Trial Outcomes & Findings for A Study of Biomarker-Driven Therapy in Metastatic Colorectal Cancer (mCRC) (NCT NCT02291289)
NCT ID: NCT02291289
Last Updated: 2024-05-06
Results Overview
PFS is defined as the time from randomization to the first occurrence of disease progression according to RECIST v1.1, or death from any cause, whichever occurs first. Progressive disease (PD) for target lesion: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of \>/=5 mm. PD for non-target lesion: Unequivocal progression of existing non-target lesions.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
1044 participants
Primary outcome timeframe
From randomization until disease progression or death from any cause, up to 5 years
Results posted on
2024-05-06
Participant Flow
Participants initially received study treatment during the Induction Phase. Next, participants within each cohort based on biomarker status were randomized to either an experimental arm or control arm per cohort in the Maintenance Phase. BRAFmut participants experiencing early disease progression during induction treatment had the option of proceeding immediately to receive second-line treatment and were followed during the study, but were not part of the Maintenance Phase study objectives.
Participant milestones
| Measure |
Cohort 4 (MP): Cobimetinib,Atezolizumab
Participants with HER2-/high microsatellite instability (MSI-H); HER2-/MSS/v-raf murine sarcoma viral oncogene homolog B1 wild type (BRAFwt); HER2-/MSS/BRAFmut/rat sarcoma mutation positive (RASmut) received 60 mg cobimetinib orally for 3 weeks followed by a 1-week treatment break and atezolizumab at a fixed dose of 840 mg via 60-minute IV infusion on Day 1 of every 2-week cycle.
|
Cohort 4 Control (MP): 5-FU/LV or Capecitabin, Bevacizumab
Per Investigator discretion, participants received fluoropyrimidine (5-FU/LV or capecitabine) at a dose and schedule per the Investigator's discretion in accordance with locally approved prescribing information and 5 mg/kg bevacizumab via 1-30 minute IV on Day 1 of every 2-week cycle.
|
Cohort 4 (IP)
Included participants with HER2-/high microsatellite instability (MSI-H); HER2-/MSS/v-raf murine sarcoma viral oncogene homolog B1 wild type (BRAFwt); HER2-/MSS/BRAFmut/rat sarcoma mutation positive (RASmut). All study participants received either eight 2-week cycles of 5-fluorouracil (5-FU)/ leucovorin calcium (LV) and oxaliplatin (FOLFOX) in combination with bevacizumab, or six 2-week cycles of FOLFOX in combination with bevacizumab, followed by two 2-week cycles of 5-FU/LV with bevacizumab during Induction Treatment.
|
Cohort 1: Induction Phase (IP)
Included participants with v-raf murine sarcoma viral oncogene homolog B1 mutation positive (BRAFmut)/human epidermal growth factor receptor 2 negative (HER2-)/microsatellite stable (MSS)/rat sarcoma wild type (RASwt). All study participants received either eight 2-week cycles of 5-fluorouracil (5-FU)/ leucovorin calcium (LV) and oxaliplatin (FOLFOX) in combination with bevacizumab, or six 2-week cycles of FOLFOX in combination with bevacizumab, followed by two 2-week cycles of 5-FU/LV with bevacizumab during Induction Treatment.
|
Cohort 1 (Maintenance Phase[MP]):5-FU/LV,Cetuximab,Vemurafenib
Participants with v-raf murine sarcoma viral oncogene homolog B1 mutation positive (BRAFmut)/human epidermal growth factor receptor 2 negative (HER2-)/microsatellite stable (MSS)/rat sarcoma wild type (RASwt) received 1600-2400 milligrams per square meter (mg/m\^2) 5-FU via 46-hour intravenous (IV) infusion in combination with 400 mg/m\^2 LV via 2-hour infusion on Day 1 of every 2-week cycle with 500 mg/m\^2 cetuximab via infusion on Day 1 of every 2-week cycle and 960 milligrams (mg) vemurafenib twice daily (BID) by mouth.
|
Cohort 1 Control (MP): 5-FU/LV or Capecitabin, Bevacizumab
Per Investigator discretion, participants received fluoropyrimidine (5-FU/LV or capecitabine) at a dose and schedule per the Investigator's discretion in accordance with locally approved prescribing information and 5 mg/kg bevacizumab via 1-30 minute IV on Day 1 of every 2-week cycle.
|
Cohort 2 (IP)
Included participants with BRAFwt. All study participants received either eight 2-week cycles of 5-fluorouracil (5-FU)/ leucovorin calcium (LV) and oxaliplatin (FOLFOX) in combination with bevacizumab, or six 2-week cycles of FOLFOX in combination with bevacizumab, followed by two 2-week cycles of 5-FU/LV with bevacizumab during Induction Treatment.
|
Cohort 2 (MP):5-FU/LV or Capecitabine,Bevacizumab,Atezolizumab
Participants with BRAFwt received fluoropyrimidine (1600-2400 mg/m\^2 5-FU via 46-hour IV infusion in combination with 400 mg/m\^2 LV via 2-hour infusion on Day 1 of every 2-week cycle or 1000 mg/m\^2 twice-daily capecitabine BID by mouth on Days 1-14 every 2 weeks followed by a 1-week break) with 5 milligrams per kilogram (mg/kg) bevacizumab via 15-30 minute IV infusion on Day 1 of every 2-week cycle and 800 mg atezolizumab via 60-minute IV infusion on Day 1 of every 2-week cycle.
|
Cohort 2 Control (MP): 5-FU/LV or Capecitabin, Bevacizumab
Per Investigator discretion, participants received fluoropyrimidine (5-FU/LV or capecitabine) at a dose and schedule per the Investigator's discretion in accordance with locally approved prescribing information and 5 mg/kg bevacizumab via 1-30 minute IV on Day 1 of every 2-week cycle.
|
Cohort 3 (IP)
Included participants with human epidermal growth factor receptor 2 positive (HER2+). All study participants received either eight 2-week cycles of 5-fluorouracil (5-FU)/ leucovorin calcium (LV) and oxaliplatin (FOLFOX) in combination with bevacizumab, or six 2-week cycles of FOLFOX in combination with bevacizumab, followed by two 2-week cycles of 5-FU/LV with bevacizumab during Induction Treatment.
|
Cohort 3 (MP): Capecitabine,Trastuzumab,Pertuzumab
Participants with human epidermal growth factor receptor 2 positive (HER2+) received 1000 mg/m\^2 twice-daily capecitabine BID by mouth on Days 1-14 every 2 weeks followed by a 1-week break with trastuzumab by IV infusion on Day 1 of every 3-week treatment cycle at an initial loading dose of 8 mg/kg followed by 6 mg/kg for subsequent doses, and pertuzumab by IV infusion on Day 1 of each 3-week treatment cycle at an initial fixed loading dose of 840 mg followed by 420 mg for subsequent doses.
|
Cohort 3 Control (MP): 5-FU/LV or Capecitabin, Bevacizumab
Per Investigator discretion, participants received fluoropyrimidine (5-FU/LV or capecitabine) at a dose and schedule per the Investigator's discretion in accordance with locally approved prescribing information and 5 mg/kg bevacizumab via 1-30 minute IV on Day 1 of every 2-week cycle.
|
Early Progressing BRAFmut Cohort
BRAFmut participants experiencing early disease progression during induction treatment had the option of proceeding immediately to receive second-line treatment with 5-FU/LV, cetuximab and vemurafenib if their primary tumor was MSS, or with a fluoropyrimidine (5-FU/LV or capecitabine), bevacizumab, and atezolizumab if their primary tumor was MSI-H. This cohort was followed during the study, but was not part of the Maintenance Phase study objectives.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Induction Treatment
STARTED
|
0
|
0
|
310
|
93
|
0
|
0
|
635
|
0
|
0
|
6
|
0
|
0
|
0
|
|
Induction Treatment
Treated During Induction Phase
|
0
|
0
|
309
|
93
|
0
|
0
|
632
|
0
|
0
|
6
|
0
|
0
|
0
|
|
Induction Treatment
COMPLETED
|
0
|
0
|
135
|
63
|
0
|
0
|
460
|
0
|
0
|
5
|
0
|
0
|
0
|
|
Induction Treatment
NOT COMPLETED
|
0
|
0
|
175
|
30
|
0
|
0
|
175
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Maintenance Treatment Phase
STARTED
|
65
|
34
|
0
|
0
|
40
|
20
|
0
|
297
|
148
|
0
|
3
|
2
|
0
|
|
Maintenance Treatment Phase
Treated During Maintenance Phase
|
64
|
34
|
0
|
0
|
40
|
18
|
0
|
293
|
143
|
0
|
3
|
2
|
0
|
|
Maintenance Treatment Phase
COMPLETED
|
12
|
6
|
0
|
0
|
6
|
2
|
0
|
66
|
21
|
0
|
0
|
1
|
0
|
|
Maintenance Treatment Phase
NOT COMPLETED
|
53
|
28
|
0
|
0
|
34
|
18
|
0
|
231
|
127
|
0
|
3
|
1
|
0
|
|
Early Disease Progression
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
11
|
|
Early Disease Progression
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Early Disease Progression
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
11
|
Reasons for withdrawal
| Measure |
Cohort 4 (MP): Cobimetinib,Atezolizumab
Participants with HER2-/high microsatellite instability (MSI-H); HER2-/MSS/v-raf murine sarcoma viral oncogene homolog B1 wild type (BRAFwt); HER2-/MSS/BRAFmut/rat sarcoma mutation positive (RASmut) received 60 mg cobimetinib orally for 3 weeks followed by a 1-week treatment break and atezolizumab at a fixed dose of 840 mg via 60-minute IV infusion on Day 1 of every 2-week cycle.
|
Cohort 4 Control (MP): 5-FU/LV or Capecitabin, Bevacizumab
Per Investigator discretion, participants received fluoropyrimidine (5-FU/LV or capecitabine) at a dose and schedule per the Investigator's discretion in accordance with locally approved prescribing information and 5 mg/kg bevacizumab via 1-30 minute IV on Day 1 of every 2-week cycle.
|
Cohort 4 (IP)
Included participants with HER2-/high microsatellite instability (MSI-H); HER2-/MSS/v-raf murine sarcoma viral oncogene homolog B1 wild type (BRAFwt); HER2-/MSS/BRAFmut/rat sarcoma mutation positive (RASmut). All study participants received either eight 2-week cycles of 5-fluorouracil (5-FU)/ leucovorin calcium (LV) and oxaliplatin (FOLFOX) in combination with bevacizumab, or six 2-week cycles of FOLFOX in combination with bevacizumab, followed by two 2-week cycles of 5-FU/LV with bevacizumab during Induction Treatment.
|
Cohort 1: Induction Phase (IP)
Included participants with v-raf murine sarcoma viral oncogene homolog B1 mutation positive (BRAFmut)/human epidermal growth factor receptor 2 negative (HER2-)/microsatellite stable (MSS)/rat sarcoma wild type (RASwt). All study participants received either eight 2-week cycles of 5-fluorouracil (5-FU)/ leucovorin calcium (LV) and oxaliplatin (FOLFOX) in combination with bevacizumab, or six 2-week cycles of FOLFOX in combination with bevacizumab, followed by two 2-week cycles of 5-FU/LV with bevacizumab during Induction Treatment.
|
Cohort 1 (Maintenance Phase[MP]):5-FU/LV,Cetuximab,Vemurafenib
Participants with v-raf murine sarcoma viral oncogene homolog B1 mutation positive (BRAFmut)/human epidermal growth factor receptor 2 negative (HER2-)/microsatellite stable (MSS)/rat sarcoma wild type (RASwt) received 1600-2400 milligrams per square meter (mg/m\^2) 5-FU via 46-hour intravenous (IV) infusion in combination with 400 mg/m\^2 LV via 2-hour infusion on Day 1 of every 2-week cycle with 500 mg/m\^2 cetuximab via infusion on Day 1 of every 2-week cycle and 960 milligrams (mg) vemurafenib twice daily (BID) by mouth.
|
Cohort 1 Control (MP): 5-FU/LV or Capecitabin, Bevacizumab
Per Investigator discretion, participants received fluoropyrimidine (5-FU/LV or capecitabine) at a dose and schedule per the Investigator's discretion in accordance with locally approved prescribing information and 5 mg/kg bevacizumab via 1-30 minute IV on Day 1 of every 2-week cycle.
|
Cohort 2 (IP)
Included participants with BRAFwt. All study participants received either eight 2-week cycles of 5-fluorouracil (5-FU)/ leucovorin calcium (LV) and oxaliplatin (FOLFOX) in combination with bevacizumab, or six 2-week cycles of FOLFOX in combination with bevacizumab, followed by two 2-week cycles of 5-FU/LV with bevacizumab during Induction Treatment.
|
Cohort 2 (MP):5-FU/LV or Capecitabine,Bevacizumab,Atezolizumab
Participants with BRAFwt received fluoropyrimidine (1600-2400 mg/m\^2 5-FU via 46-hour IV infusion in combination with 400 mg/m\^2 LV via 2-hour infusion on Day 1 of every 2-week cycle or 1000 mg/m\^2 twice-daily capecitabine BID by mouth on Days 1-14 every 2 weeks followed by a 1-week break) with 5 milligrams per kilogram (mg/kg) bevacizumab via 15-30 minute IV infusion on Day 1 of every 2-week cycle and 800 mg atezolizumab via 60-minute IV infusion on Day 1 of every 2-week cycle.
|
Cohort 2 Control (MP): 5-FU/LV or Capecitabin, Bevacizumab
Per Investigator discretion, participants received fluoropyrimidine (5-FU/LV or capecitabine) at a dose and schedule per the Investigator's discretion in accordance with locally approved prescribing information and 5 mg/kg bevacizumab via 1-30 minute IV on Day 1 of every 2-week cycle.
|
Cohort 3 (IP)
Included participants with human epidermal growth factor receptor 2 positive (HER2+). All study participants received either eight 2-week cycles of 5-fluorouracil (5-FU)/ leucovorin calcium (LV) and oxaliplatin (FOLFOX) in combination with bevacizumab, or six 2-week cycles of FOLFOX in combination with bevacizumab, followed by two 2-week cycles of 5-FU/LV with bevacizumab during Induction Treatment.
|
Cohort 3 (MP): Capecitabine,Trastuzumab,Pertuzumab
Participants with human epidermal growth factor receptor 2 positive (HER2+) received 1000 mg/m\^2 twice-daily capecitabine BID by mouth on Days 1-14 every 2 weeks followed by a 1-week break with trastuzumab by IV infusion on Day 1 of every 3-week treatment cycle at an initial loading dose of 8 mg/kg followed by 6 mg/kg for subsequent doses, and pertuzumab by IV infusion on Day 1 of each 3-week treatment cycle at an initial fixed loading dose of 840 mg followed by 420 mg for subsequent doses.
|
Cohort 3 Control (MP): 5-FU/LV or Capecitabin, Bevacizumab
Per Investigator discretion, participants received fluoropyrimidine (5-FU/LV or capecitabine) at a dose and schedule per the Investigator's discretion in accordance with locally approved prescribing information and 5 mg/kg bevacizumab via 1-30 minute IV on Day 1 of every 2-week cycle.
|
Early Progressing BRAFmut Cohort
BRAFmut participants experiencing early disease progression during induction treatment had the option of proceeding immediately to receive second-line treatment with 5-FU/LV, cetuximab and vemurafenib if their primary tumor was MSS, or with a fluoropyrimidine (5-FU/LV or capecitabine), bevacizumab, and atezolizumab if their primary tumor was MSI-H. This cohort was followed during the study, but was not part of the Maintenance Phase study objectives.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Induction Treatment
Reason Not Specified
|
0
|
0
|
7
|
0
|
0
|
0
|
4
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Induction Treatment
Withdrawal by Subject
|
0
|
0
|
18
|
0
|
0
|
0
|
24
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Induction Treatment
Adverse Event
|
0
|
0
|
1
|
0
|
0
|
0
|
3
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Induction Treatment
Death
|
0
|
0
|
82
|
25
|
0
|
0
|
111
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Induction Treatment
Lost to Follow-up
|
0
|
0
|
9
|
1
|
0
|
0
|
12
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Induction Treatment
Non-Compliance
|
0
|
0
|
1
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Induction Treatment
Physician Decision
|
0
|
0
|
1
|
0
|
0
|
0
|
3
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Induction Treatment
Protocol Violation
|
0
|
0
|
2
|
0
|
0
|
0
|
3
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Induction Treatment
Missing
|
0
|
0
|
54
|
4
|
0
|
0
|
14
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Maintenance Treatment Phase
Withdrawal by Subject
|
2
|
3
|
0
|
0
|
0
|
0
|
0
|
15
|
12
|
0
|
0
|
0
|
0
|
|
Maintenance Treatment Phase
Death
|
46
|
19
|
0
|
0
|
29
|
16
|
0
|
188
|
107
|
0
|
1
|
1
|
0
|
|
Maintenance Treatment Phase
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
0
|
0
|
0
|
|
Maintenance Treatment Phase
Lost to Follow-up
|
3
|
3
|
0
|
0
|
1
|
0
|
0
|
15
|
4
|
0
|
1
|
0
|
0
|
|
Maintenance Treatment Phase
Reason Not Specified
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
7
|
2
|
0
|
1
|
0
|
0
|
|
Maintenance Treatment Phase
Physician Decision
|
1
|
3
|
0
|
0
|
2
|
0
|
0
|
3
|
0
|
0
|
0
|
0
|
0
|
|
Maintenance Treatment Phase
Not Treated
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Maintenance Treatment Phase
Study Ended by Sponsor
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Maintenance Treatment Phase
Non-Compliance
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
2
|
1
|
0
|
0
|
0
|
0
|
|
Early Disease Progression
Death
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
10
|
|
Early Disease Progression
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
A Study of Biomarker-Driven Therapy in Metastatic Colorectal Cancer (mCRC)
Baseline characteristics by cohort
| Measure |
Cohort 1: Induction Phase (IP)
n=93 Participants
Included participants with v-raf murine sarcoma viral oncogene homolog B1 mutation positive (BRAFmut)/human epidermal growth factor receptor 2 negative (HER2-)/microsatellite stable (MSS)/rat sarcoma wild type (RASwt). All study participants received either eight 2-week cycles of 5-fluorouracil (5-FU)/ leucovorin calcium (LV) and oxaliplatin (FOLFOX) in combination with bevacizumab, or six 2-week cycles of FOLFOX in combination with bevacizumab, followed by two 2-week cycles of 5-FU/LV with bevacizumab during Induction Treatment.
|
Cohort 2 (IP)
n=635 Participants
Included participants with BRAFwt. All study participants received either eight 2-week cycles of 5-fluorouracil (5-FU)/ leucovorin calcium (LV) and oxaliplatin (FOLFOX) in combination with bevacizumab, or six 2-week cycles of FOLFOX in combination with bevacizumab, followed by two 2-week cycles of 5-FU/LV with bevacizumab during Induction Treatment.
|
Cohort 3 (IP)
n=6 Participants
Included participants with human epidermal growth factor receptor 2 positive (HER2+). All study participants received either eight 2-week cycles of 5-fluorouracil (5-FU)/ leucovorin calcium (LV) and oxaliplatin (FOLFOX) in combination with bevacizumab, or six 2-week cycles of FOLFOX in combination with bevacizumab, followed by two 2-week cycles of 5-FU/LV with bevacizumab during Induction Treatment.
|
Cohort 4 (IP)
n=310 Participants
Included participants with HER2-/high microsatellite instability (MSI-H); HER2-/MSS/v-raf murine sarcoma viral oncogene homolog B1 wild type (BRAFwt); HER2-/MSS/BRAFmut/rat sarcoma mutation positive (RASmut). All study participants received either eight 2-week cycles of 5-fluorouracil (5-FU)/ leucovorin calcium (LV) and oxaliplatin (FOLFOX) in combination with bevacizumab, or six 2-week cycles of FOLFOX in combination with bevacizumab, followed by two 2-week cycles of 5-FU/LV with bevacizumab during Induction Treatment.
|
Total
n=1044 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
59.5 years
STANDARD_DEVIATION 12.0 • n=5 Participants
|
60.9 years
STANDARD_DEVIATION 12.6 • n=7 Participants
|
48.0 years
STANDARD_DEVIATION 7.7 • n=5 Participants
|
60.1 years
STANDARD_DEVIATION 10.3 • n=4 Participants
|
60.5 years
STANDARD_DEVIATION 11.9 • n=21 Participants
|
|
Age, Customized
In utero
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Customized
Preterm newborn infants (gestational age < 37 wks)
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Customized
Newborns (0-27 days)
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Customized
Infants and toddlers (28 days-23 months)
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Customized
Children (2-11 years)
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Customized
Adolescents (12-17 years)
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Customized
Adults (18-64 years)
|
58 Participants
n=5 Participants
|
351 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
199 Participants
n=4 Participants
|
614 Participants
n=21 Participants
|
|
Age, Customized
From 65-84 years
|
35 Participants
n=5 Participants
|
279 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
110 Participants
n=4 Participants
|
424 Participants
n=21 Participants
|
|
Age, Customized
85 years and over
|
0 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
49 Participants
n=5 Participants
|
247 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
123 Participants
n=4 Participants
|
423 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
44 Participants
n=5 Participants
|
388 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
187 Participants
n=4 Participants
|
621 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
49 Participants
n=4 Participants
|
107 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
75 Participants
n=5 Participants
|
494 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
247 Participants
n=4 Participants
|
820 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
13 Participants
n=5 Participants
|
89 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
117 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
24 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
36 Participants
n=21 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
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
76 Participants
n=5 Participants
|
539 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
264 Participants
n=4 Participants
|
885 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
11 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
82 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: From randomization until disease progression or death from any cause, up to 5 yearsPopulation: Participants that were in the Maintenance Phase of the study, which included the experimental and control arms of Cohorts 1-4.
PFS is defined as the time from randomization to the first occurrence of disease progression according to RECIST v1.1, or death from any cause, whichever occurs first. Progressive disease (PD) for target lesion: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of \>/=5 mm. PD for non-target lesion: Unequivocal progression of existing non-target lesions.
Outcome measures
| Measure |
Cohort 3 (MP): Capecitabine,Trastuzumab,Pertuzumab
n=3 Participants
Participants with human epidermal growth factor receptor 2 positive (HER2+) received 1000 mg/m\^2 twice-daily capecitabine BID by mouth on Days 1-14 every 2 weeks followed by a 1-week break with trastuzumab by IV infusion on Day 1 of every 3-week treatment cycle at an initial loading dose of 8 mg/kg followed by 6 mg/kg for subsequent doses, and pertuzumab by IV infusion on Day 1 of each 3-week treatment cycle at an initial fixed loading dose of 840 mg followed by 420 mg for subsequent doses.
|
Cohort 1 (Maintenance Phase[MP]):5-FU/LV,Cetuximab,Vemurafenib
n=40 Participants
Participants with v-raf murine sarcoma viral oncogene homolog B1 mutation positive (BRAFmut)/human epidermal growth factor receptor 2 negative (HER2-)/microsatellite stable (MSS)/rat sarcoma wild type (RASwt) received 1600-2400 milligrams per square meter (mg/m\^2) 5-FU via 46-hour intravenous (IV) infusion in combination with 400 mg/m\^2 LV via 2-hour infusion on Day 1 of every 2-week cycle with 500 mg/m\^2 cetuximab via infusion on Day 1 of every 2-week cycle and 960 milligrams (mg) vemurafenib twice daily (BID) by mouth.
|
Cohort 1 Control (MP): 5-FU/LV or Capecitabin, Bevacizumab
n=20 Participants
Per Investigator discretion, participants received fluoropyrimidine (5-FU/LV or capecitabine) at a dose and schedule per the Investigator's discretion in accordance with locally approved prescribing information and 5 mg/kg bevacizumab via 1-30 minute IV on Day 1 of every 2-week cycle.
|
Cohort 2 (MP):5-FU/LV or Capecitabine,Bevacizumab,Atezolizumab
n=297 Participants
Participants with BRAFwt received fluoropyrimidine (1600-2400 mg/m\^2 5-FU via 46-hour IV infusion in combination with 400 mg/m\^2 LV via 2-hour infusion on Day 1 of every 2-week cycle or 1000 mg/m\^2 twice-daily capecitabine BID by mouth on Days 1-14 every 2 weeks followed by a 1-week break) with 5 milligrams per kilogram (mg/kg) bevacizumab via 15-30 minute IV infusion on Day 1 of every 2-week cycle and 800 mg atezolizumab via 60-minute IV infusion on Day 1 of every 2-week cycle.
|
Cohort 2 Control (MP): 5-FU/LV or Capecitabin, Bevacizumab
n=148 Participants
Per Investigator discretion, participants received fluoropyrimidine (5-FU/LV or capecitabine) at a dose and schedule per the Investigator's discretion in accordance with locally approved prescribing information and 5 mg/kg bevacizumab via 1-30 minute IV on Day 1 of every 2-week cycle.
|
Cohort 3 Control (MP): 5-FU/LV or Capecitabin, Bevacizumab
n=2 Participants
Per Investigator discretion, participants received fluoropyrimidine (5-FU/LV or capecitabine) at a dose and schedule per the Investigator's discretion in accordance with locally approved prescribing information and 5 mg/kg bevacizumab via 1-30 minute IV on Day 1 of every 2-week cycle.
|
Cohort 4 (MP): Cobimetinib,Atezolizumab
n=65 Participants
Participants with HER2-/high microsatellite instability (MSI-H); HER2-/MSS/v-raf murine sarcoma viral oncogene homolog B1 wild type (BRAFwt); HER2-/MSS/BRAFmut/rat sarcoma mutation positive (RASmut) received 60 mg cobimetinib orally for 3 weeks followed by a 1-week treatment break and atezolizumab at a fixed dose of 840 mg via 60-minute IV infusion on Day 1 of every 2-week cycle.
|
Cohort 4 Control (MP): 5-FU/LV or Capecitabin, Bevacizumab
n=34 Participants
Per Investigator discretion, participants received fluoropyrimidine (5-FU/LV or capecitabine) at a dose and schedule per the Investigator's discretion in accordance with locally approved prescribing information and 5 mg/kg bevacizumab via 1-30 minute IV on Day 1 of every 2-week cycle.
|
Cohort 3 Control (MP): 5-FU/LV or Capecitabin, Bevacizumab
Per Investigator discretion, participants received fluoropyrimidine (5-FU/LV or capecitabine) at a dose and schedule per the Investigator's discretion in accordance with locally approved prescribing information and 5 mg/kg bevacizumab via 1-30 minute IV on Day 1 of every 2-week cycle.
|
Cohort 4 (IP)
Included participants with HER2-/high microsatellite instability (MSI-H); HER2-/MSS/v-raf murine sarcoma viral oncogene homolog B1 wild type (BRAFwt); HER2-/MSS/BRAFmut/rat sarcoma mutation positive (RASmut). All study participants received either eight 2-week cycles of 5-fluorouracil (5-FU)/ leucovorin calcium (LV) and oxaliplatin (FOLFOX) in combination with bevacizumab, or six 2-week cycles of FOLFOX in combination with bevacizumab, followed by two 2-week cycles of 5-FU/LV with bevacizumab during Induction Treatment.
|
Cohort 4 (MP): Cobimetinib,Atezolizumab
Participants with HER2-/high microsatellite instability (MSI-H); HER2-/MSS/v-raf murine sarcoma viral oncogene homolog B1 wild type (BRAFwt); HER2-/MSS/BRAFmut/rat sarcoma mutation positive (RASmut) received 60 mg cobimetinib orally for 3 weeks followed by a 1-week treatment break and atezolizumab at a fixed dose of 840 mg via 60-minute IV infusion on Day 1 of every 2-week cycle.
|
Cohort 4 Control (MP): 5-FU/LV or Capecitabin, Bevacizumab
Per Investigator discretion, participants received fluoropyrimidine (5-FU/LV or capecitabine) at a dose and schedule per the Investigator's discretion in accordance with locally approved prescribing information and 5 mg/kg bevacizumab via 1-30 minute IV on Day 1 of every 2-week cycle.
|
Early Progressing BRAFmut Cohort
BRAFmut participants experiencing early disease progression during induction treatment had the option of proceeding immediately to receive second-line treatment with 5-FU/LV, cetuximab and vemurafenib if their primary tumor was MSS, or with a fluoropyrimidine (5-FU/LV or capecitabine), bevacizumab, and atezolizumab if their primary tumor was MSI-H. This cohort was followed during the study, but was not part of the Maintenance Phase study objectives.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Progression-Free Survival (PFS)
|
4.44 months
Interval 3.55 to 14.69
|
9.99 months
Interval 7.72 to 12.55
|
11.60 months
Interval 3.58 to 15.67
|
7.13 months
Interval 6.14 to 8.41
|
7.36 months
Interval 5.82 to 8.94
|
4.04 months
Interval 4.04 to 5.39
|
3.75 months
Interval 3.42 to 3.91
|
7.79 months
Interval 3.98 to 9.46
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From randomization until death from any cause, up to 5 yearsPopulation: Participants that were in the Maintenance Phase of the study, which included the experimental and control arms of Cohorts 1-4.
OS is defined as the time from randomization into the MTP to time of death from any cause.
Outcome measures
| Measure |
Cohort 3 (MP): Capecitabine,Trastuzumab,Pertuzumab
n=3 Participants
Participants with human epidermal growth factor receptor 2 positive (HER2+) received 1000 mg/m\^2 twice-daily capecitabine BID by mouth on Days 1-14 every 2 weeks followed by a 1-week break with trastuzumab by IV infusion on Day 1 of every 3-week treatment cycle at an initial loading dose of 8 mg/kg followed by 6 mg/kg for subsequent doses, and pertuzumab by IV infusion on Day 1 of each 3-week treatment cycle at an initial fixed loading dose of 840 mg followed by 420 mg for subsequent doses.
|
Cohort 1 (Maintenance Phase[MP]):5-FU/LV,Cetuximab,Vemurafenib
n=40 Participants
Participants with v-raf murine sarcoma viral oncogene homolog B1 mutation positive (BRAFmut)/human epidermal growth factor receptor 2 negative (HER2-)/microsatellite stable (MSS)/rat sarcoma wild type (RASwt) received 1600-2400 milligrams per square meter (mg/m\^2) 5-FU via 46-hour intravenous (IV) infusion in combination with 400 mg/m\^2 LV via 2-hour infusion on Day 1 of every 2-week cycle with 500 mg/m\^2 cetuximab via infusion on Day 1 of every 2-week cycle and 960 milligrams (mg) vemurafenib twice daily (BID) by mouth.
|
Cohort 1 Control (MP): 5-FU/LV or Capecitabin, Bevacizumab
n=20 Participants
Per Investigator discretion, participants received fluoropyrimidine (5-FU/LV or capecitabine) at a dose and schedule per the Investigator's discretion in accordance with locally approved prescribing information and 5 mg/kg bevacizumab via 1-30 minute IV on Day 1 of every 2-week cycle.
|
Cohort 2 (MP):5-FU/LV or Capecitabine,Bevacizumab,Atezolizumab
n=297 Participants
Participants with BRAFwt received fluoropyrimidine (1600-2400 mg/m\^2 5-FU via 46-hour IV infusion in combination with 400 mg/m\^2 LV via 2-hour infusion on Day 1 of every 2-week cycle or 1000 mg/m\^2 twice-daily capecitabine BID by mouth on Days 1-14 every 2 weeks followed by a 1-week break) with 5 milligrams per kilogram (mg/kg) bevacizumab via 15-30 minute IV infusion on Day 1 of every 2-week cycle and 800 mg atezolizumab via 60-minute IV infusion on Day 1 of every 2-week cycle.
|
Cohort 2 Control (MP): 5-FU/LV or Capecitabin, Bevacizumab
n=148 Participants
Per Investigator discretion, participants received fluoropyrimidine (5-FU/LV or capecitabine) at a dose and schedule per the Investigator's discretion in accordance with locally approved prescribing information and 5 mg/kg bevacizumab via 1-30 minute IV on Day 1 of every 2-week cycle.
|
Cohort 3 Control (MP): 5-FU/LV or Capecitabin, Bevacizumab
n=2 Participants
Per Investigator discretion, participants received fluoropyrimidine (5-FU/LV or capecitabine) at a dose and schedule per the Investigator's discretion in accordance with locally approved prescribing information and 5 mg/kg bevacizumab via 1-30 minute IV on Day 1 of every 2-week cycle.
|
Cohort 4 (MP): Cobimetinib,Atezolizumab
n=65 Participants
Participants with HER2-/high microsatellite instability (MSI-H); HER2-/MSS/v-raf murine sarcoma viral oncogene homolog B1 wild type (BRAFwt); HER2-/MSS/BRAFmut/rat sarcoma mutation positive (RASmut) received 60 mg cobimetinib orally for 3 weeks followed by a 1-week treatment break and atezolizumab at a fixed dose of 840 mg via 60-minute IV infusion on Day 1 of every 2-week cycle.
|
Cohort 4 Control (MP): 5-FU/LV or Capecitabin, Bevacizumab
n=34 Participants
Per Investigator discretion, participants received fluoropyrimidine (5-FU/LV or capecitabine) at a dose and schedule per the Investigator's discretion in accordance with locally approved prescribing information and 5 mg/kg bevacizumab via 1-30 minute IV on Day 1 of every 2-week cycle.
|
Cohort 3 Control (MP): 5-FU/LV or Capecitabin, Bevacizumab
Per Investigator discretion, participants received fluoropyrimidine (5-FU/LV or capecitabine) at a dose and schedule per the Investigator's discretion in accordance with locally approved prescribing information and 5 mg/kg bevacizumab via 1-30 minute IV on Day 1 of every 2-week cycle.
|
Cohort 4 (IP)
Included participants with HER2-/high microsatellite instability (MSI-H); HER2-/MSS/v-raf murine sarcoma viral oncogene homolog B1 wild type (BRAFwt); HER2-/MSS/BRAFmut/rat sarcoma mutation positive (RASmut). All study participants received either eight 2-week cycles of 5-fluorouracil (5-FU)/ leucovorin calcium (LV) and oxaliplatin (FOLFOX) in combination with bevacizumab, or six 2-week cycles of FOLFOX in combination with bevacizumab, followed by two 2-week cycles of 5-FU/LV with bevacizumab during Induction Treatment.
|
Cohort 4 (MP): Cobimetinib,Atezolizumab
Participants with HER2-/high microsatellite instability (MSI-H); HER2-/MSS/v-raf murine sarcoma viral oncogene homolog B1 wild type (BRAFwt); HER2-/MSS/BRAFmut/rat sarcoma mutation positive (RASmut) received 60 mg cobimetinib orally for 3 weeks followed by a 1-week treatment break and atezolizumab at a fixed dose of 840 mg via 60-minute IV infusion on Day 1 of every 2-week cycle.
|
Cohort 4 Control (MP): 5-FU/LV or Capecitabin, Bevacizumab
Per Investigator discretion, participants received fluoropyrimidine (5-FU/LV or capecitabine) at a dose and schedule per the Investigator's discretion in accordance with locally approved prescribing information and 5 mg/kg bevacizumab via 1-30 minute IV on Day 1 of every 2-week cycle.
|
Early Progressing BRAFmut Cohort
BRAFmut participants experiencing early disease progression during induction treatment had the option of proceeding immediately to receive second-line treatment with 5-FU/LV, cetuximab and vemurafenib if their primary tumor was MSS, or with a fluoropyrimidine (5-FU/LV or capecitabine), bevacizumab, and atezolizumab if their primary tumor was MSI-H. This cohort was followed during the study, but was not part of the Maintenance Phase study objectives.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Survival (OS)
|
NA months
Interval to 16.07
not evaluable
|
24.02 months
Interval 16.07 to 34.0
|
21.73 months
Interval 7.92 to 37.19
|
22.54 months
Interval 20.04 to 26.87
|
22.24 months
Interval 18.5 to 25.13
|
14.59 months
not evaluable
|
22.60 months
Interval 14.23 to 27.4
|
25.17 months
Interval 15.9 to 32.59
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From baseline until end of study (up to 5 years)Population: Safety population: all participants who received an intervention during the study.
Outcome measures
| Measure |
Cohort 3 (MP): Capecitabine,Trastuzumab,Pertuzumab
n=293 Participants
Participants with human epidermal growth factor receptor 2 positive (HER2+) received 1000 mg/m\^2 twice-daily capecitabine BID by mouth on Days 1-14 every 2 weeks followed by a 1-week break with trastuzumab by IV infusion on Day 1 of every 3-week treatment cycle at an initial loading dose of 8 mg/kg followed by 6 mg/kg for subsequent doses, and pertuzumab by IV infusion on Day 1 of each 3-week treatment cycle at an initial fixed loading dose of 840 mg followed by 420 mg for subsequent doses.
|
Cohort 1 (Maintenance Phase[MP]):5-FU/LV,Cetuximab,Vemurafenib
n=93 Participants
Participants with v-raf murine sarcoma viral oncogene homolog B1 mutation positive (BRAFmut)/human epidermal growth factor receptor 2 negative (HER2-)/microsatellite stable (MSS)/rat sarcoma wild type (RASwt) received 1600-2400 milligrams per square meter (mg/m\^2) 5-FU via 46-hour intravenous (IV) infusion in combination with 400 mg/m\^2 LV via 2-hour infusion on Day 1 of every 2-week cycle with 500 mg/m\^2 cetuximab via infusion on Day 1 of every 2-week cycle and 960 milligrams (mg) vemurafenib twice daily (BID) by mouth.
|
Cohort 1 Control (MP): 5-FU/LV or Capecitabin, Bevacizumab
n=40 Participants
Per Investigator discretion, participants received fluoropyrimidine (5-FU/LV or capecitabine) at a dose and schedule per the Investigator's discretion in accordance with locally approved prescribing information and 5 mg/kg bevacizumab via 1-30 minute IV on Day 1 of every 2-week cycle.
|
Cohort 2 (MP):5-FU/LV or Capecitabine,Bevacizumab,Atezolizumab
n=18 Participants
Participants with BRAFwt received fluoropyrimidine (1600-2400 mg/m\^2 5-FU via 46-hour IV infusion in combination with 400 mg/m\^2 LV via 2-hour infusion on Day 1 of every 2-week cycle or 1000 mg/m\^2 twice-daily capecitabine BID by mouth on Days 1-14 every 2 weeks followed by a 1-week break) with 5 milligrams per kilogram (mg/kg) bevacizumab via 15-30 minute IV infusion on Day 1 of every 2-week cycle and 800 mg atezolizumab via 60-minute IV infusion on Day 1 of every 2-week cycle.
|
Cohort 2 Control (MP): 5-FU/LV or Capecitabin, Bevacizumab
n=631 Participants
Per Investigator discretion, participants received fluoropyrimidine (5-FU/LV or capecitabine) at a dose and schedule per the Investigator's discretion in accordance with locally approved prescribing information and 5 mg/kg bevacizumab via 1-30 minute IV on Day 1 of every 2-week cycle.
|
Cohort 3 Control (MP): 5-FU/LV or Capecitabin, Bevacizumab
n=143 Participants
Per Investigator discretion, participants received fluoropyrimidine (5-FU/LV or capecitabine) at a dose and schedule per the Investigator's discretion in accordance with locally approved prescribing information and 5 mg/kg bevacizumab via 1-30 minute IV on Day 1 of every 2-week cycle.
|
Cohort 4 (MP): Cobimetinib,Atezolizumab
n=6 Participants
Participants with HER2-/high microsatellite instability (MSI-H); HER2-/MSS/v-raf murine sarcoma viral oncogene homolog B1 wild type (BRAFwt); HER2-/MSS/BRAFmut/rat sarcoma mutation positive (RASmut) received 60 mg cobimetinib orally for 3 weeks followed by a 1-week treatment break and atezolizumab at a fixed dose of 840 mg via 60-minute IV infusion on Day 1 of every 2-week cycle.
|
Cohort 4 Control (MP): 5-FU/LV or Capecitabin, Bevacizumab
n=3 Participants
Per Investigator discretion, participants received fluoropyrimidine (5-FU/LV or capecitabine) at a dose and schedule per the Investigator's discretion in accordance with locally approved prescribing information and 5 mg/kg bevacizumab via 1-30 minute IV on Day 1 of every 2-week cycle.
|
Cohort 3 Control (MP): 5-FU/LV or Capecitabin, Bevacizumab
n=2 Participants
Per Investigator discretion, participants received fluoropyrimidine (5-FU/LV or capecitabine) at a dose and schedule per the Investigator's discretion in accordance with locally approved prescribing information and 5 mg/kg bevacizumab via 1-30 minute IV on Day 1 of every 2-week cycle.
|
Cohort 4 (IP)
n=309 Participants
Included participants with HER2-/high microsatellite instability (MSI-H); HER2-/MSS/v-raf murine sarcoma viral oncogene homolog B1 wild type (BRAFwt); HER2-/MSS/BRAFmut/rat sarcoma mutation positive (RASmut). All study participants received either eight 2-week cycles of 5-fluorouracil (5-FU)/ leucovorin calcium (LV) and oxaliplatin (FOLFOX) in combination with bevacizumab, or six 2-week cycles of FOLFOX in combination with bevacizumab, followed by two 2-week cycles of 5-FU/LV with bevacizumab during Induction Treatment.
|
Cohort 4 (MP): Cobimetinib,Atezolizumab
n=64 Participants
Participants with HER2-/high microsatellite instability (MSI-H); HER2-/MSS/v-raf murine sarcoma viral oncogene homolog B1 wild type (BRAFwt); HER2-/MSS/BRAFmut/rat sarcoma mutation positive (RASmut) received 60 mg cobimetinib orally for 3 weeks followed by a 1-week treatment break and atezolizumab at a fixed dose of 840 mg via 60-minute IV infusion on Day 1 of every 2-week cycle.
|
Cohort 4 Control (MP): 5-FU/LV or Capecitabin, Bevacizumab
n=34 Participants
Per Investigator discretion, participants received fluoropyrimidine (5-FU/LV or capecitabine) at a dose and schedule per the Investigator's discretion in accordance with locally approved prescribing information and 5 mg/kg bevacizumab via 1-30 minute IV on Day 1 of every 2-week cycle.
|
Early Progressing BRAFmut Cohort
n=11 Participants
BRAFmut participants experiencing early disease progression during induction treatment had the option of proceeding immediately to receive second-line treatment with 5-FU/LV, cetuximab and vemurafenib if their primary tumor was MSS, or with a fluoropyrimidine (5-FU/LV or capecitabine), bevacizumab, and atezolizumab if their primary tumor was MSI-H. This cohort was followed during the study, but was not part of the Maintenance Phase study objectives.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Adverse Events
|
95.6 percentage of participants
|
98.9 percentage of participants
|
100 percentage of participants
|
94.4 percentage of participants
|
96.0 percentage of participants
|
88.1 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
97.4 percentage of participants
|
98.4 percentage of participants
|
88.2 percentage of participants
|
90.9 percentage of participants
|
SECONDARY outcome
Timeframe: From randomization until disease progression, up to 5 yearsPopulation: Participants that were in the Maintenance Phase of the study, which included the experimental and control arms of Cohorts 1-4.
Calculated as the number of participants with a best overall response of CR or PR according to RECIST 1.1. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. OR= CR + PR.
Outcome measures
| Measure |
Cohort 3 (MP): Capecitabine,Trastuzumab,Pertuzumab
n=3 Participants
Participants with human epidermal growth factor receptor 2 positive (HER2+) received 1000 mg/m\^2 twice-daily capecitabine BID by mouth on Days 1-14 every 2 weeks followed by a 1-week break with trastuzumab by IV infusion on Day 1 of every 3-week treatment cycle at an initial loading dose of 8 mg/kg followed by 6 mg/kg for subsequent doses, and pertuzumab by IV infusion on Day 1 of each 3-week treatment cycle at an initial fixed loading dose of 840 mg followed by 420 mg for subsequent doses.
|
Cohort 1 (Maintenance Phase[MP]):5-FU/LV,Cetuximab,Vemurafenib
n=40 Participants
Participants with v-raf murine sarcoma viral oncogene homolog B1 mutation positive (BRAFmut)/human epidermal growth factor receptor 2 negative (HER2-)/microsatellite stable (MSS)/rat sarcoma wild type (RASwt) received 1600-2400 milligrams per square meter (mg/m\^2) 5-FU via 46-hour intravenous (IV) infusion in combination with 400 mg/m\^2 LV via 2-hour infusion on Day 1 of every 2-week cycle with 500 mg/m\^2 cetuximab via infusion on Day 1 of every 2-week cycle and 960 milligrams (mg) vemurafenib twice daily (BID) by mouth.
|
Cohort 1 Control (MP): 5-FU/LV or Capecitabin, Bevacizumab
n=20 Participants
Per Investigator discretion, participants received fluoropyrimidine (5-FU/LV or capecitabine) at a dose and schedule per the Investigator's discretion in accordance with locally approved prescribing information and 5 mg/kg bevacizumab via 1-30 minute IV on Day 1 of every 2-week cycle.
|
Cohort 2 (MP):5-FU/LV or Capecitabine,Bevacizumab,Atezolizumab
n=297 Participants
Participants with BRAFwt received fluoropyrimidine (1600-2400 mg/m\^2 5-FU via 46-hour IV infusion in combination with 400 mg/m\^2 LV via 2-hour infusion on Day 1 of every 2-week cycle or 1000 mg/m\^2 twice-daily capecitabine BID by mouth on Days 1-14 every 2 weeks followed by a 1-week break) with 5 milligrams per kilogram (mg/kg) bevacizumab via 15-30 minute IV infusion on Day 1 of every 2-week cycle and 800 mg atezolizumab via 60-minute IV infusion on Day 1 of every 2-week cycle.
|
Cohort 2 Control (MP): 5-FU/LV or Capecitabin, Bevacizumab
n=148 Participants
Per Investigator discretion, participants received fluoropyrimidine (5-FU/LV or capecitabine) at a dose and schedule per the Investigator's discretion in accordance with locally approved prescribing information and 5 mg/kg bevacizumab via 1-30 minute IV on Day 1 of every 2-week cycle.
|
Cohort 3 Control (MP): 5-FU/LV or Capecitabin, Bevacizumab
n=2 Participants
Per Investigator discretion, participants received fluoropyrimidine (5-FU/LV or capecitabine) at a dose and schedule per the Investigator's discretion in accordance with locally approved prescribing information and 5 mg/kg bevacizumab via 1-30 minute IV on Day 1 of every 2-week cycle.
|
Cohort 4 (MP): Cobimetinib,Atezolizumab
n=65 Participants
Participants with HER2-/high microsatellite instability (MSI-H); HER2-/MSS/v-raf murine sarcoma viral oncogene homolog B1 wild type (BRAFwt); HER2-/MSS/BRAFmut/rat sarcoma mutation positive (RASmut) received 60 mg cobimetinib orally for 3 weeks followed by a 1-week treatment break and atezolizumab at a fixed dose of 840 mg via 60-minute IV infusion on Day 1 of every 2-week cycle.
|
Cohort 4 Control (MP): 5-FU/LV or Capecitabin, Bevacizumab
n=34 Participants
Per Investigator discretion, participants received fluoropyrimidine (5-FU/LV or capecitabine) at a dose and schedule per the Investigator's discretion in accordance with locally approved prescribing information and 5 mg/kg bevacizumab via 1-30 minute IV on Day 1 of every 2-week cycle.
|
Cohort 3 Control (MP): 5-FU/LV or Capecitabin, Bevacizumab
Per Investigator discretion, participants received fluoropyrimidine (5-FU/LV or capecitabine) at a dose and schedule per the Investigator's discretion in accordance with locally approved prescribing information and 5 mg/kg bevacizumab via 1-30 minute IV on Day 1 of every 2-week cycle.
|
Cohort 4 (IP)
Included participants with HER2-/high microsatellite instability (MSI-H); HER2-/MSS/v-raf murine sarcoma viral oncogene homolog B1 wild type (BRAFwt); HER2-/MSS/BRAFmut/rat sarcoma mutation positive (RASmut). All study participants received either eight 2-week cycles of 5-fluorouracil (5-FU)/ leucovorin calcium (LV) and oxaliplatin (FOLFOX) in combination with bevacizumab, or six 2-week cycles of FOLFOX in combination with bevacizumab, followed by two 2-week cycles of 5-FU/LV with bevacizumab during Induction Treatment.
|
Cohort 4 (MP): Cobimetinib,Atezolizumab
Participants with HER2-/high microsatellite instability (MSI-H); HER2-/MSS/v-raf murine sarcoma viral oncogene homolog B1 wild type (BRAFwt); HER2-/MSS/BRAFmut/rat sarcoma mutation positive (RASmut) received 60 mg cobimetinib orally for 3 weeks followed by a 1-week treatment break and atezolizumab at a fixed dose of 840 mg via 60-minute IV infusion on Day 1 of every 2-week cycle.
|
Cohort 4 Control (MP): 5-FU/LV or Capecitabin, Bevacizumab
Per Investigator discretion, participants received fluoropyrimidine (5-FU/LV or capecitabine) at a dose and schedule per the Investigator's discretion in accordance with locally approved prescribing information and 5 mg/kg bevacizumab via 1-30 minute IV on Day 1 of every 2-week cycle.
|
Early Progressing BRAFmut Cohort
BRAFmut participants experiencing early disease progression during induction treatment had the option of proceeding immediately to receive second-line treatment with 5-FU/LV, cetuximab and vemurafenib if their primary tumor was MSS, or with a fluoropyrimidine (5-FU/LV or capecitabine), bevacizumab, and atezolizumab if their primary tumor was MSI-H. This cohort was followed during the study, but was not part of the Maintenance Phase study objectives.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Response
|
1 Participants
|
20 Participants
|
5 Participants
|
49 Participants
|
22 Participants
|
0 Participants
|
7 Participants
|
8 Participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From randomization until disease progression, up to 5 yearsPopulation: Participants that were in the Maintenance Phase of the study, which included the experimental and control arms of Cohorts 1-4.
DCR is defined as the percentage of participants with CR, PR, or stable disease (SD) at 16 weeks. Per RECIST v1.1, CR is defined as disappearance of all target lesions. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression, taking as reference the smallest sum on study. Disease progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study including baseline, or the appearance of one or more new lesions.
Outcome measures
| Measure |
Cohort 3 (MP): Capecitabine,Trastuzumab,Pertuzumab
n=3 Participants
Participants with human epidermal growth factor receptor 2 positive (HER2+) received 1000 mg/m\^2 twice-daily capecitabine BID by mouth on Days 1-14 every 2 weeks followed by a 1-week break with trastuzumab by IV infusion on Day 1 of every 3-week treatment cycle at an initial loading dose of 8 mg/kg followed by 6 mg/kg for subsequent doses, and pertuzumab by IV infusion on Day 1 of each 3-week treatment cycle at an initial fixed loading dose of 840 mg followed by 420 mg for subsequent doses.
|
Cohort 1 (Maintenance Phase[MP]):5-FU/LV,Cetuximab,Vemurafenib
n=40 Participants
Participants with v-raf murine sarcoma viral oncogene homolog B1 mutation positive (BRAFmut)/human epidermal growth factor receptor 2 negative (HER2-)/microsatellite stable (MSS)/rat sarcoma wild type (RASwt) received 1600-2400 milligrams per square meter (mg/m\^2) 5-FU via 46-hour intravenous (IV) infusion in combination with 400 mg/m\^2 LV via 2-hour infusion on Day 1 of every 2-week cycle with 500 mg/m\^2 cetuximab via infusion on Day 1 of every 2-week cycle and 960 milligrams (mg) vemurafenib twice daily (BID) by mouth.
|
Cohort 1 Control (MP): 5-FU/LV or Capecitabin, Bevacizumab
n=20 Participants
Per Investigator discretion, participants received fluoropyrimidine (5-FU/LV or capecitabine) at a dose and schedule per the Investigator's discretion in accordance with locally approved prescribing information and 5 mg/kg bevacizumab via 1-30 minute IV on Day 1 of every 2-week cycle.
|
Cohort 2 (MP):5-FU/LV or Capecitabine,Bevacizumab,Atezolizumab
n=297 Participants
Participants with BRAFwt received fluoropyrimidine (1600-2400 mg/m\^2 5-FU via 46-hour IV infusion in combination with 400 mg/m\^2 LV via 2-hour infusion on Day 1 of every 2-week cycle or 1000 mg/m\^2 twice-daily capecitabine BID by mouth on Days 1-14 every 2 weeks followed by a 1-week break) with 5 milligrams per kilogram (mg/kg) bevacizumab via 15-30 minute IV infusion on Day 1 of every 2-week cycle and 800 mg atezolizumab via 60-minute IV infusion on Day 1 of every 2-week cycle.
|
Cohort 2 Control (MP): 5-FU/LV or Capecitabin, Bevacizumab
n=148 Participants
Per Investigator discretion, participants received fluoropyrimidine (5-FU/LV or capecitabine) at a dose and schedule per the Investigator's discretion in accordance with locally approved prescribing information and 5 mg/kg bevacizumab via 1-30 minute IV on Day 1 of every 2-week cycle.
|
Cohort 3 Control (MP): 5-FU/LV or Capecitabin, Bevacizumab
n=2 Participants
Per Investigator discretion, participants received fluoropyrimidine (5-FU/LV or capecitabine) at a dose and schedule per the Investigator's discretion in accordance with locally approved prescribing information and 5 mg/kg bevacizumab via 1-30 minute IV on Day 1 of every 2-week cycle.
|
Cohort 4 (MP): Cobimetinib,Atezolizumab
n=65 Participants
Participants with HER2-/high microsatellite instability (MSI-H); HER2-/MSS/v-raf murine sarcoma viral oncogene homolog B1 wild type (BRAFwt); HER2-/MSS/BRAFmut/rat sarcoma mutation positive (RASmut) received 60 mg cobimetinib orally for 3 weeks followed by a 1-week treatment break and atezolizumab at a fixed dose of 840 mg via 60-minute IV infusion on Day 1 of every 2-week cycle.
|
Cohort 4 Control (MP): 5-FU/LV or Capecitabin, Bevacizumab
n=34 Participants
Per Investigator discretion, participants received fluoropyrimidine (5-FU/LV or capecitabine) at a dose and schedule per the Investigator's discretion in accordance with locally approved prescribing information and 5 mg/kg bevacizumab via 1-30 minute IV on Day 1 of every 2-week cycle.
|
Cohort 3 Control (MP): 5-FU/LV or Capecitabin, Bevacizumab
Per Investigator discretion, participants received fluoropyrimidine (5-FU/LV or capecitabine) at a dose and schedule per the Investigator's discretion in accordance with locally approved prescribing information and 5 mg/kg bevacizumab via 1-30 minute IV on Day 1 of every 2-week cycle.
|
Cohort 4 (IP)
Included participants with HER2-/high microsatellite instability (MSI-H); HER2-/MSS/v-raf murine sarcoma viral oncogene homolog B1 wild type (BRAFwt); HER2-/MSS/BRAFmut/rat sarcoma mutation positive (RASmut). All study participants received either eight 2-week cycles of 5-fluorouracil (5-FU)/ leucovorin calcium (LV) and oxaliplatin (FOLFOX) in combination with bevacizumab, or six 2-week cycles of FOLFOX in combination with bevacizumab, followed by two 2-week cycles of 5-FU/LV with bevacizumab during Induction Treatment.
|
Cohort 4 (MP): Cobimetinib,Atezolizumab
Participants with HER2-/high microsatellite instability (MSI-H); HER2-/MSS/v-raf murine sarcoma viral oncogene homolog B1 wild type (BRAFwt); HER2-/MSS/BRAFmut/rat sarcoma mutation positive (RASmut) received 60 mg cobimetinib orally for 3 weeks followed by a 1-week treatment break and atezolizumab at a fixed dose of 840 mg via 60-minute IV infusion on Day 1 of every 2-week cycle.
|
Cohort 4 Control (MP): 5-FU/LV or Capecitabin, Bevacizumab
Per Investigator discretion, participants received fluoropyrimidine (5-FU/LV or capecitabine) at a dose and schedule per the Investigator's discretion in accordance with locally approved prescribing information and 5 mg/kg bevacizumab via 1-30 minute IV on Day 1 of every 2-week cycle.
|
Early Progressing BRAFmut Cohort
BRAFmut participants experiencing early disease progression during induction treatment had the option of proceeding immediately to receive second-line treatment with 5-FU/LV, cetuximab and vemurafenib if their primary tumor was MSS, or with a fluoropyrimidine (5-FU/LV or capecitabine), bevacizumab, and atezolizumab if their primary tumor was MSI-H. This cohort was followed during the study, but was not part of the Maintenance Phase study objectives.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Disease Control Rate (DCR)
|
1 Participants
|
36 Participants
|
15 Participants
|
227 Participants
|
111 Participants
|
0 Participants
|
44 Participants
|
26 Participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From randomization until disease progression or death from any cause, up to 5 yearsPopulation: Participants that were in the Maintenance Phase of the study, which included the experimental and control arms of Cohorts 1-4.
Calculated as the time from randomization to the first Occurrence of a documented Objective Response (CR or PR) determined according to RECIST 1.1. CR is defined as disappearance of all target lesions. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.
Outcome measures
| Measure |
Cohort 3 (MP): Capecitabine,Trastuzumab,Pertuzumab
n=3 Participants
Participants with human epidermal growth factor receptor 2 positive (HER2+) received 1000 mg/m\^2 twice-daily capecitabine BID by mouth on Days 1-14 every 2 weeks followed by a 1-week break with trastuzumab by IV infusion on Day 1 of every 3-week treatment cycle at an initial loading dose of 8 mg/kg followed by 6 mg/kg for subsequent doses, and pertuzumab by IV infusion on Day 1 of each 3-week treatment cycle at an initial fixed loading dose of 840 mg followed by 420 mg for subsequent doses.
|
Cohort 1 (Maintenance Phase[MP]):5-FU/LV,Cetuximab,Vemurafenib
n=40 Participants
Participants with v-raf murine sarcoma viral oncogene homolog B1 mutation positive (BRAFmut)/human epidermal growth factor receptor 2 negative (HER2-)/microsatellite stable (MSS)/rat sarcoma wild type (RASwt) received 1600-2400 milligrams per square meter (mg/m\^2) 5-FU via 46-hour intravenous (IV) infusion in combination with 400 mg/m\^2 LV via 2-hour infusion on Day 1 of every 2-week cycle with 500 mg/m\^2 cetuximab via infusion on Day 1 of every 2-week cycle and 960 milligrams (mg) vemurafenib twice daily (BID) by mouth.
|
Cohort 1 Control (MP): 5-FU/LV or Capecitabin, Bevacizumab
n=20 Participants
Per Investigator discretion, participants received fluoropyrimidine (5-FU/LV or capecitabine) at a dose and schedule per the Investigator's discretion in accordance with locally approved prescribing information and 5 mg/kg bevacizumab via 1-30 minute IV on Day 1 of every 2-week cycle.
|
Cohort 2 (MP):5-FU/LV or Capecitabine,Bevacizumab,Atezolizumab
n=297 Participants
Participants with BRAFwt received fluoropyrimidine (1600-2400 mg/m\^2 5-FU via 46-hour IV infusion in combination with 400 mg/m\^2 LV via 2-hour infusion on Day 1 of every 2-week cycle or 1000 mg/m\^2 twice-daily capecitabine BID by mouth on Days 1-14 every 2 weeks followed by a 1-week break) with 5 milligrams per kilogram (mg/kg) bevacizumab via 15-30 minute IV infusion on Day 1 of every 2-week cycle and 800 mg atezolizumab via 60-minute IV infusion on Day 1 of every 2-week cycle.
|
Cohort 2 Control (MP): 5-FU/LV or Capecitabin, Bevacizumab
n=148 Participants
Per Investigator discretion, participants received fluoropyrimidine (5-FU/LV or capecitabine) at a dose and schedule per the Investigator's discretion in accordance with locally approved prescribing information and 5 mg/kg bevacizumab via 1-30 minute IV on Day 1 of every 2-week cycle.
|
Cohort 3 Control (MP): 5-FU/LV or Capecitabin, Bevacizumab
n=2 Participants
Per Investigator discretion, participants received fluoropyrimidine (5-FU/LV or capecitabine) at a dose and schedule per the Investigator's discretion in accordance with locally approved prescribing information and 5 mg/kg bevacizumab via 1-30 minute IV on Day 1 of every 2-week cycle.
|
Cohort 4 (MP): Cobimetinib,Atezolizumab
n=65 Participants
Participants with HER2-/high microsatellite instability (MSI-H); HER2-/MSS/v-raf murine sarcoma viral oncogene homolog B1 wild type (BRAFwt); HER2-/MSS/BRAFmut/rat sarcoma mutation positive (RASmut) received 60 mg cobimetinib orally for 3 weeks followed by a 1-week treatment break and atezolizumab at a fixed dose of 840 mg via 60-minute IV infusion on Day 1 of every 2-week cycle.
|
Cohort 4 Control (MP): 5-FU/LV or Capecitabin, Bevacizumab
n=34 Participants
Per Investigator discretion, participants received fluoropyrimidine (5-FU/LV or capecitabine) at a dose and schedule per the Investigator's discretion in accordance with locally approved prescribing information and 5 mg/kg bevacizumab via 1-30 minute IV on Day 1 of every 2-week cycle.
|
Cohort 3 Control (MP): 5-FU/LV or Capecitabin, Bevacizumab
Per Investigator discretion, participants received fluoropyrimidine (5-FU/LV or capecitabine) at a dose and schedule per the Investigator's discretion in accordance with locally approved prescribing information and 5 mg/kg bevacizumab via 1-30 minute IV on Day 1 of every 2-week cycle.
|
Cohort 4 (IP)
Included participants with HER2-/high microsatellite instability (MSI-H); HER2-/MSS/v-raf murine sarcoma viral oncogene homolog B1 wild type (BRAFwt); HER2-/MSS/BRAFmut/rat sarcoma mutation positive (RASmut). All study participants received either eight 2-week cycles of 5-fluorouracil (5-FU)/ leucovorin calcium (LV) and oxaliplatin (FOLFOX) in combination with bevacizumab, or six 2-week cycles of FOLFOX in combination with bevacizumab, followed by two 2-week cycles of 5-FU/LV with bevacizumab during Induction Treatment.
|
Cohort 4 (MP): Cobimetinib,Atezolizumab
Participants with HER2-/high microsatellite instability (MSI-H); HER2-/MSS/v-raf murine sarcoma viral oncogene homolog B1 wild type (BRAFwt); HER2-/MSS/BRAFmut/rat sarcoma mutation positive (RASmut) received 60 mg cobimetinib orally for 3 weeks followed by a 1-week treatment break and atezolizumab at a fixed dose of 840 mg via 60-minute IV infusion on Day 1 of every 2-week cycle.
|
Cohort 4 Control (MP): 5-FU/LV or Capecitabin, Bevacizumab
Per Investigator discretion, participants received fluoropyrimidine (5-FU/LV or capecitabine) at a dose and schedule per the Investigator's discretion in accordance with locally approved prescribing information and 5 mg/kg bevacizumab via 1-30 minute IV on Day 1 of every 2-week cycle.
|
Early Progressing BRAFmut Cohort
BRAFmut participants experiencing early disease progression during induction treatment had the option of proceeding immediately to receive second-line treatment with 5-FU/LV, cetuximab and vemurafenib if their primary tumor was MSS, or with a fluoropyrimidine (5-FU/LV or capecitabine), bevacizumab, and atezolizumab if their primary tumor was MSI-H. This cohort was followed during the study, but was not part of the Maintenance Phase study objectives.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time to Treatment Response
|
5.490 months
Interval 5.49 to 5.49
|
3.943 months
Interval 1.18 to 29.7
|
5.552 months
Interval 1.38 to 8.02
|
5.224 months
Interval 1.22 to 26.74
|
4.616 months
Interval 1.25 to 19.91
|
0 months
Interval 0.0 to 0.0
|
3.745 months
Interval 1.77 to 14.92
|
2.530 months
Interval 1.64 to 11.83
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first objective response until disease progression or death from any cause, up to 5 yearsPopulation: Participants that were in the Maintenance Phase of the study, which included the experimental and control arms of Cohorts 1-4.
Defined as the time from the first assessment of CR or PR until disease progression or death from any cause, whichever occurs first. CR is defined as disappearance of all target lesions. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.
Outcome measures
| Measure |
Cohort 3 (MP): Capecitabine,Trastuzumab,Pertuzumab
n=3 Participants
Participants with human epidermal growth factor receptor 2 positive (HER2+) received 1000 mg/m\^2 twice-daily capecitabine BID by mouth on Days 1-14 every 2 weeks followed by a 1-week break with trastuzumab by IV infusion on Day 1 of every 3-week treatment cycle at an initial loading dose of 8 mg/kg followed by 6 mg/kg for subsequent doses, and pertuzumab by IV infusion on Day 1 of each 3-week treatment cycle at an initial fixed loading dose of 840 mg followed by 420 mg for subsequent doses.
|
Cohort 1 (Maintenance Phase[MP]):5-FU/LV,Cetuximab,Vemurafenib
n=40 Participants
Participants with v-raf murine sarcoma viral oncogene homolog B1 mutation positive (BRAFmut)/human epidermal growth factor receptor 2 negative (HER2-)/microsatellite stable (MSS)/rat sarcoma wild type (RASwt) received 1600-2400 milligrams per square meter (mg/m\^2) 5-FU via 46-hour intravenous (IV) infusion in combination with 400 mg/m\^2 LV via 2-hour infusion on Day 1 of every 2-week cycle with 500 mg/m\^2 cetuximab via infusion on Day 1 of every 2-week cycle and 960 milligrams (mg) vemurafenib twice daily (BID) by mouth.
|
Cohort 1 Control (MP): 5-FU/LV or Capecitabin, Bevacizumab
n=20 Participants
Per Investigator discretion, participants received fluoropyrimidine (5-FU/LV or capecitabine) at a dose and schedule per the Investigator's discretion in accordance with locally approved prescribing information and 5 mg/kg bevacizumab via 1-30 minute IV on Day 1 of every 2-week cycle.
|
Cohort 2 (MP):5-FU/LV or Capecitabine,Bevacizumab,Atezolizumab
n=297 Participants
Participants with BRAFwt received fluoropyrimidine (1600-2400 mg/m\^2 5-FU via 46-hour IV infusion in combination with 400 mg/m\^2 LV via 2-hour infusion on Day 1 of every 2-week cycle or 1000 mg/m\^2 twice-daily capecitabine BID by mouth on Days 1-14 every 2 weeks followed by a 1-week break) with 5 milligrams per kilogram (mg/kg) bevacizumab via 15-30 minute IV infusion on Day 1 of every 2-week cycle and 800 mg atezolizumab via 60-minute IV infusion on Day 1 of every 2-week cycle.
|
Cohort 2 Control (MP): 5-FU/LV or Capecitabin, Bevacizumab
n=148 Participants
Per Investigator discretion, participants received fluoropyrimidine (5-FU/LV or capecitabine) at a dose and schedule per the Investigator's discretion in accordance with locally approved prescribing information and 5 mg/kg bevacizumab via 1-30 minute IV on Day 1 of every 2-week cycle.
|
Cohort 3 Control (MP): 5-FU/LV or Capecitabin, Bevacizumab
n=2 Participants
Per Investigator discretion, participants received fluoropyrimidine (5-FU/LV or capecitabine) at a dose and schedule per the Investigator's discretion in accordance with locally approved prescribing information and 5 mg/kg bevacizumab via 1-30 minute IV on Day 1 of every 2-week cycle.
|
Cohort 4 (MP): Cobimetinib,Atezolizumab
n=65 Participants
Participants with HER2-/high microsatellite instability (MSI-H); HER2-/MSS/v-raf murine sarcoma viral oncogene homolog B1 wild type (BRAFwt); HER2-/MSS/BRAFmut/rat sarcoma mutation positive (RASmut) received 60 mg cobimetinib orally for 3 weeks followed by a 1-week treatment break and atezolizumab at a fixed dose of 840 mg via 60-minute IV infusion on Day 1 of every 2-week cycle.
|
Cohort 4 Control (MP): 5-FU/LV or Capecitabin, Bevacizumab
n=34 Participants
Per Investigator discretion, participants received fluoropyrimidine (5-FU/LV or capecitabine) at a dose and schedule per the Investigator's discretion in accordance with locally approved prescribing information and 5 mg/kg bevacizumab via 1-30 minute IV on Day 1 of every 2-week cycle.
|
Cohort 3 Control (MP): 5-FU/LV or Capecitabin, Bevacizumab
Per Investigator discretion, participants received fluoropyrimidine (5-FU/LV or capecitabine) at a dose and schedule per the Investigator's discretion in accordance with locally approved prescribing information and 5 mg/kg bevacizumab via 1-30 minute IV on Day 1 of every 2-week cycle.
|
Cohort 4 (IP)
Included participants with HER2-/high microsatellite instability (MSI-H); HER2-/MSS/v-raf murine sarcoma viral oncogene homolog B1 wild type (BRAFwt); HER2-/MSS/BRAFmut/rat sarcoma mutation positive (RASmut). All study participants received either eight 2-week cycles of 5-fluorouracil (5-FU)/ leucovorin calcium (LV) and oxaliplatin (FOLFOX) in combination with bevacizumab, or six 2-week cycles of FOLFOX in combination with bevacizumab, followed by two 2-week cycles of 5-FU/LV with bevacizumab during Induction Treatment.
|
Cohort 4 (MP): Cobimetinib,Atezolizumab
Participants with HER2-/high microsatellite instability (MSI-H); HER2-/MSS/v-raf murine sarcoma viral oncogene homolog B1 wild type (BRAFwt); HER2-/MSS/BRAFmut/rat sarcoma mutation positive (RASmut) received 60 mg cobimetinib orally for 3 weeks followed by a 1-week treatment break and atezolizumab at a fixed dose of 840 mg via 60-minute IV infusion on Day 1 of every 2-week cycle.
|
Cohort 4 Control (MP): 5-FU/LV or Capecitabin, Bevacizumab
Per Investigator discretion, participants received fluoropyrimidine (5-FU/LV or capecitabine) at a dose and schedule per the Investigator's discretion in accordance with locally approved prescribing information and 5 mg/kg bevacizumab via 1-30 minute IV on Day 1 of every 2-week cycle.
|
Early Progressing BRAFmut Cohort
BRAFmut participants experiencing early disease progression during induction treatment had the option of proceeding immediately to receive second-line treatment with 5-FU/LV, cetuximab and vemurafenib if their primary tumor was MSS, or with a fluoropyrimidine (5-FU/LV or capecitabine), bevacizumab, and atezolizumab if their primary tumor was MSI-H. This cohort was followed during the study, but was not part of the Maintenance Phase study objectives.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Duration of Response
|
9.205 months
Interval 9.205 to 9.205
|
11.50 months
Interval 7.66 to 21.49
|
8.74 months
Interval 5.36 to 19.02
|
9.30 months
Interval 5.55 to 11.3
|
7.59 months
Interval 6.93 to 13.9
|
0 months
Interval 0.0 to 0.0
|
7.11 months
Interval 1.48 to
Upper value of the 95% CI cannot be calculated because it is above the maximum value observed.
|
6.06 months
Interval 2.2 to 7.33
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From baseline until end of study (up to 5 years)Population: Participants that were in the Maintenance Phase of the study, which included the experimental and control arms of Cohorts 1-4.
Outcome measures
| Measure |
Cohort 3 (MP): Capecitabine,Trastuzumab,Pertuzumab
n=3 Participants
Participants with human epidermal growth factor receptor 2 positive (HER2+) received 1000 mg/m\^2 twice-daily capecitabine BID by mouth on Days 1-14 every 2 weeks followed by a 1-week break with trastuzumab by IV infusion on Day 1 of every 3-week treatment cycle at an initial loading dose of 8 mg/kg followed by 6 mg/kg for subsequent doses, and pertuzumab by IV infusion on Day 1 of each 3-week treatment cycle at an initial fixed loading dose of 840 mg followed by 420 mg for subsequent doses.
|
Cohort 1 (Maintenance Phase[MP]):5-FU/LV,Cetuximab,Vemurafenib
n=40 Participants
Participants with v-raf murine sarcoma viral oncogene homolog B1 mutation positive (BRAFmut)/human epidermal growth factor receptor 2 negative (HER2-)/microsatellite stable (MSS)/rat sarcoma wild type (RASwt) received 1600-2400 milligrams per square meter (mg/m\^2) 5-FU via 46-hour intravenous (IV) infusion in combination with 400 mg/m\^2 LV via 2-hour infusion on Day 1 of every 2-week cycle with 500 mg/m\^2 cetuximab via infusion on Day 1 of every 2-week cycle and 960 milligrams (mg) vemurafenib twice daily (BID) by mouth.
|
Cohort 1 Control (MP): 5-FU/LV or Capecitabin, Bevacizumab
n=20 Participants
Per Investigator discretion, participants received fluoropyrimidine (5-FU/LV or capecitabine) at a dose and schedule per the Investigator's discretion in accordance with locally approved prescribing information and 5 mg/kg bevacizumab via 1-30 minute IV on Day 1 of every 2-week cycle.
|
Cohort 2 (MP):5-FU/LV or Capecitabine,Bevacizumab,Atezolizumab
n=297 Participants
Participants with BRAFwt received fluoropyrimidine (1600-2400 mg/m\^2 5-FU via 46-hour IV infusion in combination with 400 mg/m\^2 LV via 2-hour infusion on Day 1 of every 2-week cycle or 1000 mg/m\^2 twice-daily capecitabine BID by mouth on Days 1-14 every 2 weeks followed by a 1-week break) with 5 milligrams per kilogram (mg/kg) bevacizumab via 15-30 minute IV infusion on Day 1 of every 2-week cycle and 800 mg atezolizumab via 60-minute IV infusion on Day 1 of every 2-week cycle.
|
Cohort 2 Control (MP): 5-FU/LV or Capecitabin, Bevacizumab
n=148 Participants
Per Investigator discretion, participants received fluoropyrimidine (5-FU/LV or capecitabine) at a dose and schedule per the Investigator's discretion in accordance with locally approved prescribing information and 5 mg/kg bevacizumab via 1-30 minute IV on Day 1 of every 2-week cycle.
|
Cohort 3 Control (MP): 5-FU/LV or Capecitabin, Bevacizumab
n=2 Participants
Per Investigator discretion, participants received fluoropyrimidine (5-FU/LV or capecitabine) at a dose and schedule per the Investigator's discretion in accordance with locally approved prescribing information and 5 mg/kg bevacizumab via 1-30 minute IV on Day 1 of every 2-week cycle.
|
Cohort 4 (MP): Cobimetinib,Atezolizumab
n=65 Participants
Participants with HER2-/high microsatellite instability (MSI-H); HER2-/MSS/v-raf murine sarcoma viral oncogene homolog B1 wild type (BRAFwt); HER2-/MSS/BRAFmut/rat sarcoma mutation positive (RASmut) received 60 mg cobimetinib orally for 3 weeks followed by a 1-week treatment break and atezolizumab at a fixed dose of 840 mg via 60-minute IV infusion on Day 1 of every 2-week cycle.
|
Cohort 4 Control (MP): 5-FU/LV or Capecitabin, Bevacizumab
n=34 Participants
Per Investigator discretion, participants received fluoropyrimidine (5-FU/LV or capecitabine) at a dose and schedule per the Investigator's discretion in accordance with locally approved prescribing information and 5 mg/kg bevacizumab via 1-30 minute IV on Day 1 of every 2-week cycle.
|
Cohort 3 Control (MP): 5-FU/LV or Capecitabin, Bevacizumab
Per Investigator discretion, participants received fluoropyrimidine (5-FU/LV or capecitabine) at a dose and schedule per the Investigator's discretion in accordance with locally approved prescribing information and 5 mg/kg bevacizumab via 1-30 minute IV on Day 1 of every 2-week cycle.
|
Cohort 4 (IP)
Included participants with HER2-/high microsatellite instability (MSI-H); HER2-/MSS/v-raf murine sarcoma viral oncogene homolog B1 wild type (BRAFwt); HER2-/MSS/BRAFmut/rat sarcoma mutation positive (RASmut). All study participants received either eight 2-week cycles of 5-fluorouracil (5-FU)/ leucovorin calcium (LV) and oxaliplatin (FOLFOX) in combination with bevacizumab, or six 2-week cycles of FOLFOX in combination with bevacizumab, followed by two 2-week cycles of 5-FU/LV with bevacizumab during Induction Treatment.
|
Cohort 4 (MP): Cobimetinib,Atezolizumab
Participants with HER2-/high microsatellite instability (MSI-H); HER2-/MSS/v-raf murine sarcoma viral oncogene homolog B1 wild type (BRAFwt); HER2-/MSS/BRAFmut/rat sarcoma mutation positive (RASmut) received 60 mg cobimetinib orally for 3 weeks followed by a 1-week treatment break and atezolizumab at a fixed dose of 840 mg via 60-minute IV infusion on Day 1 of every 2-week cycle.
|
Cohort 4 Control (MP): 5-FU/LV or Capecitabin, Bevacizumab
Per Investigator discretion, participants received fluoropyrimidine (5-FU/LV or capecitabine) at a dose and schedule per the Investigator's discretion in accordance with locally approved prescribing information and 5 mg/kg bevacizumab via 1-30 minute IV on Day 1 of every 2-week cycle.
|
Early Progressing BRAFmut Cohort
BRAFmut participants experiencing early disease progression during induction treatment had the option of proceeding immediately to receive second-line treatment with 5-FU/LV, cetuximab and vemurafenib if their primary tumor was MSS, or with a fluoropyrimidine (5-FU/LV or capecitabine), bevacizumab, and atezolizumab if their primary tumor was MSI-H. This cohort was followed during the study, but was not part of the Maintenance Phase study objectives.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Improvement and/or Stayed the Same on the Eastern Cooperative Oncology Group Performance Status (ECOG PS) Score
Improved or stayed the same
|
100 percentage of participants
|
75.0 percentage of participants
|
85.0 percentage of participants
|
76.7 percentage of participants
|
82.5 percentage of participants
|
100 percentage of participants
|
63.1 percentage of participants
|
79.4 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Improvement and/or Stayed the Same on the Eastern Cooperative Oncology Group Performance Status (ECOG PS) Score
Improved
|
0 percentage of participants
|
10.0 percentage of participants
|
5.0 percentage of participants
|
10.4 percentage of participants
|
5.4 percentage of participants
|
0 percentage of participants
|
7.7 percentage of participants
|
5.9 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Cohort 3 (IP)
Serious events: 1 serious events
Other events: 6 other events
Deaths: 1 deaths
Cohort 1 (Maintenance Phase[MP]):5-FU/LV,Cetuximab,Vemurafenib
Serious events: 15 serious events
Other events: 40 other events
Deaths: 29 deaths
Cohort 1 Control (MP): 5-FU/LV or Capecitabin, Bevacizumab
Serious events: 5 serious events
Other events: 17 other events
Deaths: 16 deaths
Cohort 2 (IP)
Serious events: 232 serious events
Other events: 608 other events
Deaths: 111 deaths
Cohort 2 (MP):5-FU/LV or Capecitabine,Bevacizumab,Atezolizumab
Serious events: 76 serious events
Other events: 270 other events
Deaths: 188 deaths
Cohort 2 Control (MP): 5-FU/LV or Capecitabin, Bevacizumab
Serious events: 20 serious events
Other events: 120 other events
Deaths: 107 deaths
Cohort 1: Induction Phase (IP)
Serious events: 44 serious events
Other events: 91 other events
Deaths: 25 deaths
Cohort 3 (MP): Capecitabine,Trastuzumab,Pertuzumab
Serious events: 0 serious events
Other events: 3 other events
Deaths: 1 deaths
Cohort 3 Control (MP): 5-FU/LV or Capecitabin, Bevacizumab
Serious events: 0 serious events
Other events: 2 other events
Deaths: 1 deaths
Cohort 4 (IP)
Serious events: 93 serious events
Other events: 298 other events
Deaths: 82 deaths
Cohort 4 (MP): Cobimetinib,Atezolizumab
Serious events: 26 serious events
Other events: 61 other events
Deaths: 46 deaths
Cohort 4 Control (MP): 5-FU/LV or Capecitabin, Bevacizumab
Serious events: 3 serious events
Other events: 29 other events
Deaths: 19 deaths
Early Progressing BRAFmut Cohort
Serious events: 3 serious events
Other events: 11 other events
Deaths: 10 deaths
Serious adverse events
| Measure |
Cohort 3 (IP)
n=6 participants at risk
Included participants with human epidermal growth factor receptor 2 positive (HER2+). All study participants received either eight 2-week cycles of 5-fluorouracil (5-FU)/ leucovorin calcium (LV) and oxaliplatin (FOLFOX) in combination with bevacizumab, or six 2-week cycles of FOLFOX in combination with bevacizumab, followed by two 2-week cycles of 5-FU/LV with bevacizumab during Induction Treatment.
|
Cohort 1 (Maintenance Phase[MP]):5-FU/LV,Cetuximab,Vemurafenib
n=40 participants at risk
Participants with v-raf murine sarcoma viral oncogene homolog B1 mutation positive (BRAFmut)/human epidermal growth factor receptor 2 negative (HER2-)/microsatellite stable (MSS)/rat sarcoma wild type (RASwt) received 1600-2400 milligrams per square meter (mg/m\^2) 5-FU via 46-hour intravenous (IV) infusion in combination with 400 mg/m\^2 LV via 2-hour infusion on Day 1 of every 2-week cycle with 500 mg/m\^2 cetuximab via infusion on Day 1 of every 2-week cycle and 960 milligrams (mg) vemurafenib twice daily (BID) by mouth.
|
Cohort 1 Control (MP): 5-FU/LV or Capecitabin, Bevacizumab
n=18 participants at risk
Per Investigator discretion, participants received fluoropyrimidine (5-FU/LV or capecitabine) at a dose and schedule per the Investigator's discretion in accordance with locally approved prescribing information and 5 mg/kg bevacizumab via 1-30 minute IV on Day 1 of every 2-week cycle.
|
Cohort 2 (IP)
n=632 participants at risk
Included participants with BRAFwt. All study participants received either eight 2-week cycles of 5-fluorouracil (5-FU)/ leucovorin calcium (LV) and oxaliplatin (FOLFOX) in combination with bevacizumab, or six 2-week cycles of FOLFOX in combination with bevacizumab, followed by two 2-week cycles of 5-FU/LV with bevacizumab during Induction Treatment.
|
Cohort 2 (MP):5-FU/LV or Capecitabine,Bevacizumab,Atezolizumab
n=293 participants at risk
Participants with BRAFwt received fluoropyrimidine (1600-2400 mg/m\^2 5-FU via 46-hour IV infusion in combination with 400 mg/m\^2 LV via 2-hour infusion on Day 1 of every 2-week cycle or 1000 mg/m\^2 twice-daily capecitabine BID by mouth on Days 1-14 every 2 weeks followed by a 1-week break) with 5 milligrams per kilogram (mg/kg) bevacizumab via 15-30 minute IV infusion on Day 1 of every 2-week cycle and 800 mg atezolizumab via 60-minute IV infusion on Day 1 of every 2-week cycle.
|
Cohort 2 Control (MP): 5-FU/LV or Capecitabin, Bevacizumab
n=143 participants at risk
Per Investigator discretion, participants received fluoropyrimidine (5-FU/LV or capecitabine) at a dose and schedule per the Investigator's discretion in accordance with locally approved prescribing information and 5 mg/kg bevacizumab via 1-30 minute IV on Day 1 of every 2-week cycle.
|
Cohort 1: Induction Phase (IP)
n=93 participants at risk
Included participants with v-raf murine sarcoma viral oncogene homolog B1 mutation positive (BRAFmut)/human epidermal growth factor receptor 2 negative (HER2-)/microsatellite stable (MSS)/rat sarcoma wild type (RASwt). All study participants received either eight 2-week cycles of 5-fluorouracil (5-FU)/ leucovorin calcium (LV) and oxaliplatin (FOLFOX) in combination with bevacizumab, or six 2-week cycles of FOLFOX in combination with bevacizumab, followed by two 2-week cycles of 5-FU/LV with bevacizumab during Induction Treatment.
|
Cohort 3 (MP): Capecitabine,Trastuzumab,Pertuzumab
n=3 participants at risk
Participants with human epidermal growth factor receptor 2 positive (HER2+) received 1000 mg/m\^2 twice-daily capecitabine BID by mouth on Days 1-14 every 2 weeks followed by a 1-week break with trastuzumab by IV infusion on Day 1 of every 3-week treatment cycle at an initial loading dose of 8 mg/kg followed by 6 mg/kg for subsequent doses, and pertuzumab by IV infusion on Day 1 of each 3-week treatment cycle at an initial fixed loading dose of 840 mg followed by 420 mg for subsequent doses.
|
Cohort 3 Control (MP): 5-FU/LV or Capecitabin, Bevacizumab
n=2 participants at risk
Per Investigator discretion, participants received fluoropyrimidine (5-FU/LV or capecitabine) at a dose and schedule per the Investigator's discretion in accordance with locally approved prescribing information and 5 mg/kg bevacizumab via 1-30 minute IV on Day 1 of every 2-week cycle.
|
Cohort 4 (IP)
n=309 participants at risk
Included participants with HER2-/high microsatellite instability (MSI-H); HER2-/MSS/v-raf murine sarcoma viral oncogene homolog B1 wild type (BRAFwt); HER2-/MSS/BRAFmut/rat sarcoma mutation positive (RASmut). All study participants received either eight 2-week cycles of 5-fluorouracil (5-FU)/ leucovorin calcium (LV) and oxaliplatin (FOLFOX) in combination with bevacizumab, or six 2-week cycles of FOLFOX in combination with bevacizumab, followed by two 2-week cycles of 5-FU/LV with bevacizumab during Induction Treatment.
|
Cohort 4 (MP): Cobimetinib,Atezolizumab
n=64 participants at risk
Participants with HER2-/high microsatellite instability (MSI-H); HER2-/MSS/v-raf murine sarcoma viral oncogene homolog B1 wild type (BRAFwt); HER2-/MSS/BRAFmut/rat sarcoma mutation positive (RASmut) received 60 mg cobimetinib orally for 3 weeks followed by a 1-week treatment break and atezolizumab at a fixed dose of 840 mg via 60-minute IV infusion on Day 1 of every 2-week cycle.
|
Cohort 4 Control (MP): 5-FU/LV or Capecitabin, Bevacizumab
n=34 participants at risk
Per Investigator discretion, participants received fluoropyrimidine (5-FU/LV or capecitabine) at a dose and schedule per the Investigator's discretion in accordance with locally approved prescribing information and 5 mg/kg bevacizumab via 1-30 minute IV on Day 1 of every 2-week cycle.
|
Early Progressing BRAFmut Cohort
n=11 participants at risk
BRAFmut participants experiencing early disease progression during induction treatment had the option of proceeding immediately to receive second-line treatment with 5-FU/LV, cetuximab and vemurafenib if their primary tumor was MSS, or with a fluoropyrimidine (5-FU/LV or capecitabine), bevacizumab, and atezolizumab if their primary tumor was MSI-H. This cohort was followed during the study, but was not part of the Maintenance Phase study objectives.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.32%
2/632 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.34%
1/293 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.5%
1/40 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
5.6%
1/18 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.6%
10/632 • Number of events 10 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.68%
2/293 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.2%
2/93 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.65%
2/309 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Gastrointestinal disorders
Immune-mediated enterocolitis
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/632 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.32%
1/309 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.6%
1/64 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Gastrointestinal disorders
Large intestinal haemorrhage
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.16%
1/632 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Gastrointestinal disorders
Pneumatosis intestinalis
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.16%
1/632 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.5%
1/40 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.16%
1/632 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.1%
1/93 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.32%
1/309 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.9%
12/632 • Number of events 13 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.34%
1/293 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.2%
2/93 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.3%
4/309 • Number of events 4 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.16%
1/632 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.70%
1/143 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.16%
1/632 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.34%
1/293 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.16%
1/632 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.32%
1/309 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.6%
1/64 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Cardiac disorders
Cardiogenic shock
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/632 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.32%
1/309 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.6%
1/64 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.5%
1/40 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/632 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.1%
1/93 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.5%
1/40 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.16%
1/632 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.34%
1/293 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.1%
1/93 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Cardiac disorders
Restrictive cardiomyopathy
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.16%
1/632 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.34%
1/293 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Infections and infestations
Infectious pleural effusion
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.16%
1/632 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.16%
1/632 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.34%
1/293 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.16%
1/632 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.34%
1/293 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Eye disorders
Chorioretinopathy
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/632 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.32%
1/309 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.6%
1/64 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.5%
1/40 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.63%
4/632 • Number of events 4 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.34%
1/293 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.70%
1/143 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.2%
2/93 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.9%
6/309 • Number of events 6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.6%
1/64 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
9.1%
1/11 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.16%
1/632 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.34%
1/293 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.47%
3/632 • Number of events 3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.0%
3/293 • Number of events 3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.97%
3/309 • Number of events 3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.6%
1/64 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.9%
1/34 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.1%
7/632 • Number of events 9 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.34%
1/293 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.70%
1/143 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.97%
3/309 • Number of events 3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.5%
1/40 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
5.6%
1/18 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.1%
13/632 • Number of events 14 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.7%
5/293 • Number of events 5 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.4%
2/143 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
5.4%
5/93 • Number of events 5 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.3%
4/309 • Number of events 5 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
3.1%
2/64 • Number of events 3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
9.1%
1/11 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Gastrointestinal disorders
Faecaloma
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.16%
1/632 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.70%
1/143 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.47%
3/632 • Number of events 3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.34%
1/293 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.1%
1/93 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.47%
3/632 • Number of events 3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.34%
1/293 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.79%
5/632 • Number of events 5 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.34%
1/293 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.70%
1/143 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.1%
1/93 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.3%
4/309 • Number of events 4 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.6%
1/64 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.63%
4/632 • Number of events 4 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.34%
1/293 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.65%
2/309 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Gastrointestinal disorders
Large intestinal stenosis
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.16%
1/632 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.34%
1/293 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.47%
3/632 • Number of events 3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.34%
1/293 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.70%
1/143 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.1%
1/93 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.65%
2/309 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.47%
3/632 • Number of events 3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.34%
1/293 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.70%
1/143 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.5%
1/40 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.47%
3/632 • Number of events 3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.68%
2/293 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.1%
1/93 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.16%
1/632 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.34%
1/293 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.32%
1/309 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.16%
1/632 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.34%
1/293 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.32%
1/309 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.63%
4/632 • Number of events 4 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.34%
1/293 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Gastrointestinal disorders
Subileus
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.47%
3/632 • Number of events 4 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.68%
2/293 • Number of events 3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.97%
3/309 • Number of events 4 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.6%
1/64 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.16%
1/632 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.34%
1/293 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.6%
10/632 • Number of events 10 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.4%
4/293 • Number of events 4 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.2%
2/93 • Number of events 4 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.32%
1/309 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
General disorders
Asthenia
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.32%
2/632 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.1%
1/93 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Infections and infestations
Hepatobiliary infection
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.16%
1/632 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
General disorders
Chest pain
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.5%
1/40 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.32%
2/632 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.34%
1/293 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.70%
1/143 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.1%
1/93 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
General disorders
Gait disturbance
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.16%
1/632 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.34%
1/293 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
General disorders
General physical health deterioration
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.5%
1/40 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.95%
6/632 • Number of events 6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.68%
2/293 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.1%
1/93 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.32%
1/309 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
General disorders
Implant site thrombosis
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
5.6%
1/18 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/632 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.1%
1/93 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
General disorders
Infusion site extravasation
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.16%
1/632 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.34%
1/293 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
General disorders
Pyrexia
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.2%
14/632 • Number of events 15 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.0%
6/293 • Number of events 6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.1%
1/93 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.6%
8/309 • Number of events 9 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
3.1%
2/64 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Hepatobiliary disorders
Cholestasis
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
5.6%
1/18 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/632 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.2%
2/93 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.32%
2/632 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.34%
1/293 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Hepatobiliary disorders
Hepatitis
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.16%
1/632 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.34%
1/293 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Hepatobiliary disorders
Hepatocellular injury
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.16%
1/632 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.34%
1/293 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Hepatobiliary disorders
Hepatorenal failure
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.16%
1/632 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.34%
1/293 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Hepatobiliary disorders
Hepatotoxicity
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.16%
1/632 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.34%
1/293 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.32%
1/309 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/632 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.32%
1/309 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.32%
2/632 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.68%
2/293 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Infections and infestations
Abdominal infection
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.32%
2/632 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.70%
1/143 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.1%
1/93 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.32%
1/309 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Infections and infestations
Abdominal wall abscess
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
5.6%
1/18 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/632 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.2%
2/93 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Infections and infestations
Anal abscess
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.32%
2/632 • Number of events 3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.70%
1/143 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Infections and infestations
Arthritis infective
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.16%
1/632 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.70%
1/143 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.32%
2/632 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.34%
1/293 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.65%
2/309 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Infections and infestations
Device related infection
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
5.6%
1/18 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.32%
2/632 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.34%
1/293 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.2%
2/93 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.5%
1/40 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.16%
1/632 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.1%
1/93 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Infections and infestations
Erysipelas
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/632 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.32%
1/309 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.6%
1/64 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.47%
3/632 • Number of events 3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.68%
2/293 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.1%
1/93 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
9.1%
1/11 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Infections and infestations
Gingivitis
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
5.6%
1/18 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/632 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.1%
1/93 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Infections and infestations
Hepatic infection
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.5%
1/40 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/632 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.1%
1/93 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Infections and infestations
Infection
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.47%
3/632 • Number of events 3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.34%
1/293 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.70%
1/143 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.32%
1/309 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Infections and infestations
Large intestine infection
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/632 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.32%
1/309 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.6%
1/64 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.3%
8/632 • Number of events 8 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.34%
1/293 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.70%
1/143 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.1%
1/93 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.3%
4/309 • Number of events 5 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.6%
1/64 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Infections and infestations
Post procedural sepsis
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.16%
1/632 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.34%
1/293 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Infections and infestations
Rectal abscess
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.16%
1/632 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.34%
1/293 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.32%
2/632 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.34%
1/293 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.32%
1/309 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.6%
1/64 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Infections and infestations
Sepsis
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.95%
6/632 • Number of events 7 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.68%
2/293 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.32%
1/309 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Infections and infestations
Septic shock
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.16%
1/632 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.34%
1/293 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
5.6%
1/18 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/632 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.1%
1/93 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.5%
1/40 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/632 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.1%
1/93 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.3%
8/632 • Number of events 8 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.0%
3/293 • Number of events 3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.1%
1/93 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.65%
2/309 • Number of events 3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
3.1%
2/64 • Number of events 3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.47%
3/632 • Number of events 3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.70%
1/143 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Infections and infestations
Vascular device infection
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.95%
6/632 • Number of events 7 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.70%
1/143 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Injury, poisoning and procedural complications
Anastomotic ulcer
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.16%
1/632 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.34%
1/293 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.47%
3/632 • Number of events 3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.34%
1/293 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.70%
1/143 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.16%
1/632 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.70%
1/143 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.5%
1/40 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/632 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.1%
1/93 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.5%
1/40 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/632 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.1%
1/93 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.5%
1/40 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.16%
1/632 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.1%
1/93 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.16%
1/632 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.70%
1/143 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Injury, poisoning and procedural complications
Tracheal haemorrhage
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.16%
1/632 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.34%
1/293 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/632 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.97%
3/309 • Number of events 3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
4.7%
3/64 • Number of events 3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.16%
1/632 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.34%
1/293 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Investigations
Blood triglycerides increased
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.16%
1/632 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.34%
1/293 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Investigations
Lipase increased
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.5%
1/40 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/632 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.1%
1/93 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.47%
3/632 • Number of events 3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
3.2%
3/93 • Number of events 5 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.97%
3/309 • Number of events 3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.6%
1/64 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
9.1%
1/11 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.16%
1/632 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.34%
1/293 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/632 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.32%
1/309 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.6%
1/64 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/632 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.32%
1/309 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.9%
1/34 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/632 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.32%
1/309 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.9%
1/34 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.5%
1/40 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/632 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.1%
1/93 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.16%
1/632 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.34%
1/293 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leiomyosarcoma
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.16%
1/632 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.34%
1/293 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Second primary malignancy
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.16%
1/632 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.70%
1/143 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour perforation
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.5%
1/40 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/632 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.1%
1/93 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.47%
3/632 • Number of events 3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.34%
1/293 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.70%
1/143 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.65%
2/309 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.9%
1/34 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.16%
1/632 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.34%
1/293 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.16%
1/632 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.34%
1/293 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Nervous system disorders
Syncope
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.16%
1/632 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.70%
1/143 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.1%
1/93 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.32%
1/309 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/632 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.32%
1/309 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.6%
1/64 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.79%
5/632 • Number of events 6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.34%
1/293 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.70%
1/143 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.6%
8/309 • Number of events 11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
3.1%
2/64 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.16%
1/632 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.34%
1/293 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.5%
1/40 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.16%
1/632 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.1%
1/93 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.65%
2/309 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/632 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.32%
1/309 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.6%
1/64 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.16%
1/632 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.34%
1/293 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.1%
1/93 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Organising pneumonia
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/632 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.32%
1/309 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.6%
1/64 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.16%
1/632 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.34%
1/293 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.97%
3/309 • Number of events 3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
3.1%
2/64 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.5%
1/40 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/632 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.1%
1/93 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.1%
7/632 • Number of events 7 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.34%
1/293 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.1%
1/93 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.65%
2/309 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.16%
1/632 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.34%
1/293 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.32%
1/309 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/632 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.32%
1/309 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.6%
1/64 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/632 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.32%
1/309 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.6%
1/64 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Vascular disorders
Arterial thrombosis
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.32%
2/632 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.34%
1/293 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.47%
3/632 • Number of events 3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.34%
1/293 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.1%
1/93 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Vascular disorders
Hypertension
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.95%
6/632 • Number of events 6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.0%
3/293 • Number of events 3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Vascular disorders
Hypotension
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.32%
2/632 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.34%
1/293 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.32%
1/309 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Vascular disorders
Superior vena cava syndrome
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.16%
1/632 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.34%
1/293 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Vascular disorders
Thrombosis
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.16%
1/632 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.34%
1/293 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.32%
1/309 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.6%
10/632 • Number of events 13 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.65%
2/309 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.16%
1/632 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/632 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.1%
1/93 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Gastrointestinal disorders
Gastrointestinal obstruction
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.32%
2/632 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.16%
1/632 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.79%
5/632 • Number of events 7 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.1%
1/93 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.32%
1/309 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.32%
2/632 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.16%
1/632 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.32%
1/309 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
General disorders
Fatigue
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.16%
1/632 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.32%
1/309 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
General disorders
Hyperthermia
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.16%
1/632 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
General disorders
Implant site dehiscence
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/632 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.32%
1/309 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.16%
1/632 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Infections and infestations
Abdominal abscess
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.16%
1/632 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.32%
1/309 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Infections and infestations
Gastroenteritis clostridial
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.16%
1/632 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Infections and infestations
Labyrinthitis
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/632 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.1%
1/93 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.16%
1/632 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/632 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.32%
1/309 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/632 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.1%
1/93 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Injury, poisoning and procedural complications
Stoma site haemorrhage
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.16%
1/632 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.16%
1/632 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.47%
3/632 • Number of events 4 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.1%
1/93 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.16%
1/632 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.16%
1/632 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.32%
1/309 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.32%
2/632 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.32%
1/309 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.16%
1/632 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/632 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.1%
1/93 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/632 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.32%
1/309 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Psychiatric disorders
Disorientation
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/632 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.1%
1/93 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/632 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.1%
1/93 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.16%
1/632 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Surgical and medical procedures
Ureteral stent removal
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.16%
1/632 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Vascular disorders
Haemorrhage
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/632 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.32%
1/309 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.16%
1/632 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.1%
1/93 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.32%
2/632 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Blood and lymphatic system disorders
Splenic haematoma
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/632 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.32%
1/309 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.32%
2/632 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Cardiac disorders
Atrial thrombosis
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.16%
1/632 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Cardiac disorders
Cardiac tamponade
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.16%
1/632 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.16%
1/632 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Eye disorders
Choroidal effusion
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/632 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.1%
1/93 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Eye disorders
Retinal haemorrhage
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.16%
1/632 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Gastrointestinal disorders
Anal fistula
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.32%
2/632 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Gastrointestinal disorders
Colonic fistula
|
16.7%
1/6 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/632 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.16%
1/632 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Gastrointestinal disorders
Gastrointestinal necrosis
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.16%
1/632 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Gastrointestinal disorders
Gastrointestinal perforation
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.32%
2/632 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Gastrointestinal disorders
Rectal perforation
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.16%
1/632 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.32%
1/309 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Gastrointestinal disorders
Small intestinal perforation
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.16%
1/632 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.1%
1/93 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Gastrointestinal disorders
Thrombosis mesenteric vessel
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/632 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.32%
1/309 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
General disorders
Death
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.32%
2/632 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
General disorders
Euthanasia
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.16%
1/632 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
General disorders
Influenza like illness
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/632 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.32%
1/309 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.32%
2/632 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.32%
1/309 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/632 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.32%
1/309 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/632 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.1%
1/93 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Immune system disorders
Infusion related hypersensitivity reaction
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/632 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.1%
1/93 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Infections and infestations
Bacterial sepsis
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.16%
1/632 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Infections and infestations
Catheter site infection
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.16%
1/632 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Infections and infestations
Encephalitis
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/632 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.32%
1/309 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Infections and infestations
Fournier's gangrene
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/632 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.32%
1/309 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Infections and infestations
Gastroenteritis norovirus
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/632 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.32%
1/309 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Infections and infestations
Influenza
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/632 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.65%
2/309 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Infections and infestations
Intervertebral discitis
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.16%
1/632 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Infections and infestations
Pelvic abscess
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.16%
1/632 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Infections and infestations
Perirectal abscess
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.16%
1/632 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Infections and infestations
Peritonitis
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.16%
1/632 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.32%
1/309 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Infections and infestations
Pilonidal cyst
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/632 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.32%
1/309 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Infections and infestations
Pseudomembranous colitis
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.16%
1/632 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.16%
1/632 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/632 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.32%
1/309 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Injury, poisoning and procedural complications
Postoperative thoracic procedure complication
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.16%
1/632 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Injury, poisoning and procedural complications
Gastrointestinal anastomotic leak
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.16%
1/632 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Injury, poisoning and procedural complications
Incision site impaired healing
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.16%
1/632 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.16%
1/632 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/632 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.32%
1/309 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Investigations
Amylase increased
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/632 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.32%
1/309 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/632 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.1%
1/93 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Investigations
Influenza A virus test positive
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/632 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.32%
1/309 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Investigations
Platelet count decreased
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/632 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.32%
1/309 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/632 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.32%
1/309 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/632 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.65%
2/309 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Musculoskeletal and connective tissue disorders
Fistula
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/632 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.32%
1/309 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroendocrine tumour
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.16%
1/632 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.16%
1/632 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Nervous system disorders
Hemiplegia
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.16%
1/632 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Nervous system disorders
Reversible cerebral vasoconstriction syndrome
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.16%
1/632 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Nervous system disorders
Seizure
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/632 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.32%
1/309 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/632 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.32%
1/309 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.16%
1/632 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.16%
1/632 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.16%
1/632 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.16%
1/632 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoventilation
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/632 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.32%
1/309 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.16%
1/632 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary thrombosis
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/632 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.32%
1/309 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.16%
1/632 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/632 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.32%
1/309 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.16%
1/632 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Skin and subcutaneous tissue disorders
Paraneoplastic dermatomyositis
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/632 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.32%
1/309 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Vascular disorders
Dry gangrene
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.16%
1/632 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Vascular disorders
Embolism
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.16%
1/632 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.65%
2/309 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Vascular disorders
Embolism venous
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/632 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.65%
2/309 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Vascular disorders
Peripheral artery occlusion
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.16%
1/632 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Vascular disorders
Subclavian vein thrombosis
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.16%
1/632 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
Other adverse events
| Measure |
Cohort 3 (IP)
n=6 participants at risk
Included participants with human epidermal growth factor receptor 2 positive (HER2+). All study participants received either eight 2-week cycles of 5-fluorouracil (5-FU)/ leucovorin calcium (LV) and oxaliplatin (FOLFOX) in combination with bevacizumab, or six 2-week cycles of FOLFOX in combination with bevacizumab, followed by two 2-week cycles of 5-FU/LV with bevacizumab during Induction Treatment.
|
Cohort 1 (Maintenance Phase[MP]):5-FU/LV,Cetuximab,Vemurafenib
n=40 participants at risk
Participants with v-raf murine sarcoma viral oncogene homolog B1 mutation positive (BRAFmut)/human epidermal growth factor receptor 2 negative (HER2-)/microsatellite stable (MSS)/rat sarcoma wild type (RASwt) received 1600-2400 milligrams per square meter (mg/m\^2) 5-FU via 46-hour intravenous (IV) infusion in combination with 400 mg/m\^2 LV via 2-hour infusion on Day 1 of every 2-week cycle with 500 mg/m\^2 cetuximab via infusion on Day 1 of every 2-week cycle and 960 milligrams (mg) vemurafenib twice daily (BID) by mouth.
|
Cohort 1 Control (MP): 5-FU/LV or Capecitabin, Bevacizumab
n=18 participants at risk
Per Investigator discretion, participants received fluoropyrimidine (5-FU/LV or capecitabine) at a dose and schedule per the Investigator's discretion in accordance with locally approved prescribing information and 5 mg/kg bevacizumab via 1-30 minute IV on Day 1 of every 2-week cycle.
|
Cohort 2 (IP)
n=632 participants at risk
Included participants with BRAFwt. All study participants received either eight 2-week cycles of 5-fluorouracil (5-FU)/ leucovorin calcium (LV) and oxaliplatin (FOLFOX) in combination with bevacizumab, or six 2-week cycles of FOLFOX in combination with bevacizumab, followed by two 2-week cycles of 5-FU/LV with bevacizumab during Induction Treatment.
|
Cohort 2 (MP):5-FU/LV or Capecitabine,Bevacizumab,Atezolizumab
n=293 participants at risk
Participants with BRAFwt received fluoropyrimidine (1600-2400 mg/m\^2 5-FU via 46-hour IV infusion in combination with 400 mg/m\^2 LV via 2-hour infusion on Day 1 of every 2-week cycle or 1000 mg/m\^2 twice-daily capecitabine BID by mouth on Days 1-14 every 2 weeks followed by a 1-week break) with 5 milligrams per kilogram (mg/kg) bevacizumab via 15-30 minute IV infusion on Day 1 of every 2-week cycle and 800 mg atezolizumab via 60-minute IV infusion on Day 1 of every 2-week cycle.
|
Cohort 2 Control (MP): 5-FU/LV or Capecitabin, Bevacizumab
n=143 participants at risk
Per Investigator discretion, participants received fluoropyrimidine (5-FU/LV or capecitabine) at a dose and schedule per the Investigator's discretion in accordance with locally approved prescribing information and 5 mg/kg bevacizumab via 1-30 minute IV on Day 1 of every 2-week cycle.
|
Cohort 1: Induction Phase (IP)
n=93 participants at risk
Included participants with v-raf murine sarcoma viral oncogene homolog B1 mutation positive (BRAFmut)/human epidermal growth factor receptor 2 negative (HER2-)/microsatellite stable (MSS)/rat sarcoma wild type (RASwt). All study participants received either eight 2-week cycles of 5-fluorouracil (5-FU)/ leucovorin calcium (LV) and oxaliplatin (FOLFOX) in combination with bevacizumab, or six 2-week cycles of FOLFOX in combination with bevacizumab, followed by two 2-week cycles of 5-FU/LV with bevacizumab during Induction Treatment.
|
Cohort 3 (MP): Capecitabine,Trastuzumab,Pertuzumab
n=3 participants at risk
Participants with human epidermal growth factor receptor 2 positive (HER2+) received 1000 mg/m\^2 twice-daily capecitabine BID by mouth on Days 1-14 every 2 weeks followed by a 1-week break with trastuzumab by IV infusion on Day 1 of every 3-week treatment cycle at an initial loading dose of 8 mg/kg followed by 6 mg/kg for subsequent doses, and pertuzumab by IV infusion on Day 1 of each 3-week treatment cycle at an initial fixed loading dose of 840 mg followed by 420 mg for subsequent doses.
|
Cohort 3 Control (MP): 5-FU/LV or Capecitabin, Bevacizumab
n=2 participants at risk
Per Investigator discretion, participants received fluoropyrimidine (5-FU/LV or capecitabine) at a dose and schedule per the Investigator's discretion in accordance with locally approved prescribing information and 5 mg/kg bevacizumab via 1-30 minute IV on Day 1 of every 2-week cycle.
|
Cohort 4 (IP)
n=309 participants at risk
Included participants with HER2-/high microsatellite instability (MSI-H); HER2-/MSS/v-raf murine sarcoma viral oncogene homolog B1 wild type (BRAFwt); HER2-/MSS/BRAFmut/rat sarcoma mutation positive (RASmut). All study participants received either eight 2-week cycles of 5-fluorouracil (5-FU)/ leucovorin calcium (LV) and oxaliplatin (FOLFOX) in combination with bevacizumab, or six 2-week cycles of FOLFOX in combination with bevacizumab, followed by two 2-week cycles of 5-FU/LV with bevacizumab during Induction Treatment.
|
Cohort 4 (MP): Cobimetinib,Atezolizumab
n=64 participants at risk
Participants with HER2-/high microsatellite instability (MSI-H); HER2-/MSS/v-raf murine sarcoma viral oncogene homolog B1 wild type (BRAFwt); HER2-/MSS/BRAFmut/rat sarcoma mutation positive (RASmut) received 60 mg cobimetinib orally for 3 weeks followed by a 1-week treatment break and atezolizumab at a fixed dose of 840 mg via 60-minute IV infusion on Day 1 of every 2-week cycle.
|
Cohort 4 Control (MP): 5-FU/LV or Capecitabin, Bevacizumab
n=34 participants at risk
Per Investigator discretion, participants received fluoropyrimidine (5-FU/LV or capecitabine) at a dose and schedule per the Investigator's discretion in accordance with locally approved prescribing information and 5 mg/kg bevacizumab via 1-30 minute IV on Day 1 of every 2-week cycle.
|
Early Progressing BRAFmut Cohort
n=11 participants at risk
BRAFmut participants experiencing early disease progression during induction treatment had the option of proceeding immediately to receive second-line treatment with 5-FU/LV, cetuximab and vemurafenib if their primary tumor was MSS, or with a fluoropyrimidine (5-FU/LV or capecitabine), bevacizumab, and atezolizumab if their primary tumor was MSI-H. This cohort was followed during the study, but was not part of the Maintenance Phase study objectives.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Investigations
Blood bilirubin increased
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
5.0%
2/40 • Number of events 3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
5.6%
1/18 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.8%
18/632 • Number of events 24 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.7%
8/293 • Number of events 10 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
3.5%
5/143 • Number of events 6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
4.3%
4/93 • Number of events 6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.3%
4/309 • Number of events 4 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.6%
1/64 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Investigations
Blood creatine phosphokinase increased
|
16.7%
1/6 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/632 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
33.3%
1/3 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
10.4%
32/309 • Number of events 40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
48.4%
31/64 • Number of events 39 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Investigations
Weight increased
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.5%
1/40 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.6%
10/632 • Number of events 11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.68%
2/293 • Number of events 3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.70%
1/143 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.1%
1/93 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.6%
8/309 • Number of events 14 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
4.7%
3/64 • Number of events 7 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
5.9%
2/34 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
10.0%
4/40 • Number of events 6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.1%
13/632 • Number of events 19 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.4%
4/293 • Number of events 4 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.70%
1/143 • Number of events 4 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
5.4%
5/93 • Number of events 8 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.3%
7/309 • Number of events 7 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.6%
1/64 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
9.1%
1/11 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.16%
1/632 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.70%
1/143 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.9%
6/309 • Number of events 7 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
7.8%
5/64 • Number of events 6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Investigations
Lipase increased
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
7.5%
3/40 • Number of events 3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.32%
2/632 • Number of events 3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.68%
2/293 • Number of events 3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
4.3%
4/93 • Number of events 4 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.9%
9/309 • Number of events 12 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
7.8%
5/64 • Number of events 7 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
9.1%
1/11 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Investigations
Platelet count decreased
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.5%
1/40 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
6.3%
40/632 • Number of events 74 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.0%
6/293 • Number of events 19 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.1%
3/143 • Number of events 4 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
4.3%
4/93 • Number of events 7 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
8.7%
27/309 • Number of events 37 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
9.4%
6/64 • Number of events 7 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.9%
1/34 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Investigations
Weight decreased
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
10.0%
4/40 • Number of events 4 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
11.1%
2/18 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
10.1%
64/632 • Number of events 69 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
3.8%
11/293 • Number of events 12 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.4%
2/143 • Number of events 3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
11.8%
11/93 • Number of events 12 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
9.7%
30/309 • Number of events 31 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
9.4%
6/64 • Number of events 6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
5.0%
2/40 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
5.6%
1/18 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
21.0%
133/632 • Number of events 220 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
4.1%
12/293 • Number of events 12 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
5.6%
8/143 • Number of events 17 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
23.7%
22/93 • Number of events 31 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
25.2%
78/309 • Number of events 123 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
10.9%
7/64 • Number of events 9 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
8.8%
3/34 • Number of events 4 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Gastrointestinal disorders
Angular cheilitis
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.5%
1/40 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
5.6%
1/18 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.32%
2/632 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.2%
2/93 • Number of events 3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.32%
1/309 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Blood and lymphatic system disorders
Anaemia
|
16.7%
1/6 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
17.5%
7/40 • Number of events 10 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
5.6%
1/18 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
13.8%
87/632 • Number of events 114 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
7.2%
21/293 • Number of events 27 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
5.6%
8/143 • Number of events 13 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
21.5%
20/93 • Number of events 28 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
15.9%
49/309 • Number of events 62 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
12.5%
8/64 • Number of events 10 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.9%
1/34 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
9.1%
1/11 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.5%
1/40 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
6.3%
40/632 • Number of events 57 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.4%
4/293 • Number of events 8 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.1%
3/143 • Number of events 3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
5.4%
5/93 • Number of events 6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
3.6%
11/309 • Number of events 14 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.9%
1/34 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
7.1%
45/632 • Number of events 67 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
3.4%
10/293 • Number of events 12 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.8%
4/143 • Number of events 10 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
4.3%
4/93 • Number of events 5 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
7.1%
22/309 • Number of events 45 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
6.2%
4/64 • Number of events 4 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.9%
1/34 • Number of events 5 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.8%
18/632 • Number of events 19 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
5.5%
16/293 • Number of events 17 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.1%
1/93 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.32%
1/309 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.6%
1/64 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
4.1%
26/632 • Number of events 34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
8.2%
24/293 • Number of events 32 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.70%
1/143 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.1%
1/93 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.97%
3/309 • Number of events 3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
4.7%
3/64 • Number of events 3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Eye disorders
Cataract
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
10.0%
4/40 • Number of events 5 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.47%
3/632 • Number of events 4 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.68%
2/293 • Number of events 3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
4.3%
4/93 • Number of events 5 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.3%
4/309 • Number of events 4 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
4.7%
3/64 • Number of events 3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
5.6%
1/18 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.32%
2/632 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.70%
1/143 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.1%
1/93 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
5.6%
1/18 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.2%
14/632 • Number of events 17 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.4%
4/293 • Number of events 5 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
3.5%
5/143 • Number of events 5 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.1%
1/93 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.65%
2/309 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
General disorders
Pyrexia
|
33.3%
2/6 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
20.0%
8/40 • Number of events 8 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
5.6%
1/18 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
14.7%
93/632 • Number of events 144 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
10.9%
32/293 • Number of events 52 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
9.1%
13/143 • Number of events 14 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
20.4%
19/93 • Number of events 20 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
18.1%
56/309 • Number of events 76 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
31.2%
20/64 • Number of events 27 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
8.8%
3/34 • Number of events 3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Eye disorders
Periorbital oedema
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
5.6%
1/18 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.32%
2/632 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.68%
2/293 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
3.2%
3/93 • Number of events 3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Eye disorders
Visual impairment
|
16.7%
1/6 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.5%
1/40 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.1%
7/632 • Number of events 7 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.68%
2/293 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.1%
1/93 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
33.3%
1/3 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.32%
1/309 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Gastrointestinal disorders
Abdominal pain
|
16.7%
1/6 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
20.0%
8/40 • Number of events 10 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
5.6%
1/18 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
17.9%
113/632 • Number of events 152 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
13.3%
39/293 • Number of events 44 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
8.4%
12/143 • Number of events 15 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
30.1%
28/93 • Number of events 34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
14.6%
45/309 • Number of events 56 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
18.8%
12/64 • Number of events 15 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
14.7%
5/34 • Number of events 5 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
36.4%
4/11 • Number of events 5 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
5.0%
2/40 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
16.7%
3/18 • Number of events 3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
8.9%
56/632 • Number of events 69 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
6.1%
18/293 • Number of events 22 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
7.7%
11/143 • Number of events 15 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
12.9%
12/93 • Number of events 14 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
6.5%
20/309 • Number of events 21 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
7.8%
5/64 • Number of events 6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.9%
1/34 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Gastrointestinal disorders
Constipation
|
33.3%
2/6 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
12.5%
5/40 • Number of events 6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
25.0%
158/632 • Number of events 235 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
13.0%
38/293 • Number of events 48 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
11.9%
17/143 • Number of events 26 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
24.7%
23/93 • Number of events 27 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
50.0%
1/2 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
18.8%
58/309 • Number of events 74 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
10.9%
7/64 • Number of events 9 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
5.9%
2/34 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
9.1%
1/11 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Gastrointestinal disorders
Dental cyst
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
5.6%
1/18 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/632 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.1%
1/93 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
66.7%
4/6 • Number of events 9 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
40.0%
16/40 • Number of events 43 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
22.2%
4/18 • Number of events 5 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
44.6%
282/632 • Number of events 539 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
26.6%
78/293 • Number of events 120 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
14.7%
21/143 • Number of events 36 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
55.9%
52/93 • Number of events 104 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
66.7%
2/3 • Number of events 5 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
43.4%
134/309 • Number of events 276 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
62.5%
40/64 • Number of events 87 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
23.5%
8/34 • Number of events 11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
45.5%
5/11 • Number of events 5 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
12.5%
5/40 • Number of events 6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
16.7%
3/18 • Number of events 3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
22.8%
144/632 • Number of events 225 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
11.9%
35/293 • Number of events 50 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
7.7%
11/143 • Number of events 19 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
25.8%
24/93 • Number of events 36 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
12.9%
40/309 • Number of events 52 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.6%
1/64 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
8.8%
3/34 • Number of events 3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
9.1%
1/11 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.5%
1/40 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
5.6%
1/18 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
5.5%
35/632 • Number of events 43 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
3.4%
10/293 • Number of events 12 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.8%
4/143 • Number of events 4 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
7.5%
7/93 • Number of events 9 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
6.1%
19/309 • Number of events 19 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.6%
1/64 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
5.0%
2/40 • Number of events 4 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.7%
17/632 • Number of events 24 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.34%
1/293 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.70%
1/143 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
4.3%
4/93 • Number of events 8 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
3.2%
10/309 • Number of events 10 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.6%
1/64 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
5.9%
2/34 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Gastrointestinal disorders
Gingival bleeding
|
16.7%
1/6 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
5.0%
2/40 • Number of events 3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.4%
9/632 • Number of events 9 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.7%
5/293 • Number of events 5 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.2%
2/93 • Number of events 3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
50.0%
1/2 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.5%
1/40 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
5.6%
1/18 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
3.5%
22/632 • Number of events 24 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.7%
5/293 • Number of events 5 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.70%
1/143 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
7.5%
7/93 • Number of events 7 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.3%
7/309 • Number of events 7 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
3.1%
2/64 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Gastrointestinal disorders
Toothache
|
16.7%
1/6 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
3.6%
23/632 • Number of events 26 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.7%
8/293 • Number of events 8 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.4%
2/143 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
33.3%
1/3 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.97%
3/309 • Number of events 3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.6%
1/64 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Gastrointestinal disorders
Nausea
|
33.3%
2/6 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
40.0%
16/40 • Number of events 23 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
47.2%
298/632 • Number of events 589 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
21.8%
64/293 • Number of events 134 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
18.9%
27/143 • Number of events 41 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
57.0%
53/93 • Number of events 106 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
41.7%
129/309 • Number of events 246 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
26.6%
17/64 • Number of events 22 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
17.6%
6/34 • Number of events 22 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
27.3%
3/11 • Number of events 4 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Gastrointestinal disorders
Palatal ulcer
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
5.6%
1/18 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/632 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.1%
1/93 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
5.0%
2/40 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
5.6%
1/18 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.8%
18/632 • Number of events 22 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.0%
6/293 • Number of events 6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.8%
4/143 • Number of events 6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
4.3%
4/93 • Number of events 4 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.97%
3/309 • Number of events 4 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
9.1%
1/11 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
1/6 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
20.0%
8/40 • Number of events 12 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
5.6%
1/18 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
24.1%
152/632 • Number of events 243 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
13.3%
39/293 • Number of events 61 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
5.6%
8/143 • Number of events 11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
31.2%
29/93 • Number of events 46 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
21.4%
66/309 • Number of events 101 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
20.3%
13/64 • Number of events 19 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
8.8%
3/34 • Number of events 9 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
36.4%
4/11 • Number of events 5 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
General disorders
Asthenia
|
16.7%
1/6 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
12.5%
5/40 • Number of events 9 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
5.6%
1/18 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
18.2%
115/632 • Number of events 214 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
13.7%
40/293 • Number of events 58 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
8.4%
12/143 • Number of events 20 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
21.5%
20/93 • Number of events 32 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
20.4%
63/309 • Number of events 111 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
20.3%
13/64 • Number of events 18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
8.8%
3/34 • Number of events 3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
9.1%
1/11 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
General disorders
Face oedema
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.47%
3/632 • Number of events 5 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.34%
1/293 • Number of events 3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.6%
5/309 • Number of events 5 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
7.8%
5/64 • Number of events 5 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
General disorders
Fatigue
|
66.7%
4/6 • Number of events 6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
22.5%
9/40 • Number of events 11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
11.1%
2/18 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
39.1%
247/632 • Number of events 403 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
17.7%
52/293 • Number of events 77 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
16.1%
23/143 • Number of events 27 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
33.3%
31/93 • Number of events 50 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
33.3%
1/3 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
28.2%
87/309 • Number of events 138 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
18.8%
12/64 • Number of events 20 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
20.6%
7/34 • Number of events 8 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
27.3%
3/11 • Number of events 3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
General disorders
Influenza like illness
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
5.0%
2/40 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
3.3%
21/632 • Number of events 22 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
3.1%
9/293 • Number of events 10 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.1%
3/143 • Number of events 3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
5.4%
5/93 • Number of events 5 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
3.2%
10/309 • Number of events 10 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.6%
1/64 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.9%
1/34 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
9.1%
1/11 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
General disorders
Malaise
|
16.7%
1/6 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.5%
1/40 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.3%
8/632 • Number of events 9 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.7%
5/293 • Number of events 5 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.70%
1/143 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.2%
2/93 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
33.3%
1/3 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.3%
4/309 • Number of events 4 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.6%
1/64 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
General disorders
Mucosal inflammation
|
50.0%
3/6 • Number of events 3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
17.5%
7/40 • Number of events 8 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
11.1%
2/18 • Number of events 4 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
10.9%
69/632 • Number of events 90 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
6.8%
20/293 • Number of events 26 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
4.9%
7/143 • Number of events 9 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
17.2%
16/93 • Number of events 22 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
33.3%
1/3 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
18.4%
57/309 • Number of events 72 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
6.2%
4/64 • Number of events 5 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.9%
1/34 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
18.2%
2/11 • Number of events 3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
General disorders
Oedema peripheral
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
7.5%
3/40 • Number of events 6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
4.0%
25/632 • Number of events 25 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.7%
8/293 • Number of events 8 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.4%
2/143 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
9.7%
9/93 • Number of events 13 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
5.2%
16/309 • Number of events 18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
9.4%
6/64 • Number of events 8 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.9%
1/34 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
18.2%
2/11 • Number of events 3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
General disorders
Pain
|
16.7%
1/6 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
7.5%
3/40 • Number of events 3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.5%
16/632 • Number of events 16 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.4%
4/293 • Number of events 4 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.70%
1/143 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
3.2%
3/93 • Number of events 3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
33.3%
1/3 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.32%
1/309 • Number of events 3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
7.5%
3/40 • Number of events 3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.4%
15/632 • Number of events 15 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.68%
2/293 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.70%
1/143 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
3.2%
3/93 • Number of events 3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.3%
4/309 • Number of events 5 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.6%
1/64 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
5.6%
1/18 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.7%
17/632 • Number of events 17 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.7%
5/293 • Number of events 5 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.1%
3/143 • Number of events 3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.2%
2/93 • Number of events 3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.97%
3/309 • Number of events 3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
7.5%
3/40 • Number of events 3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
5.6%
1/18 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.5%
16/632 • Number of events 18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.7%
5/293 • Number of events 6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.4%
2/143 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
5.4%
5/93 • Number of events 6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.6%
5/309 • Number of events 5 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
3.1%
2/64 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.9%
1/34 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Infections and infestations
Cystitis
|
16.7%
1/6 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.3%
8/632 • Number of events 9 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.68%
2/293 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.70%
1/143 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
33.3%
1/3 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.65%
2/309 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.6%
1/64 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Infections and infestations
Device related infection
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
5.0%
2/40 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.3%
8/632 • Number of events 10 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.68%
2/293 • Number of events 3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.2%
2/93 • Number of events 3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.32%
1/309 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Infections and infestations
Eye infection
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
5.6%
1/18 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/632 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.1%
1/93 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
15.0%
6/40 • Number of events 8 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.63%
4/632 • Number of events 5 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.68%
2/293 • Number of events 3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.70%
1/143 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
8.6%
8/93 • Number of events 11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.32%
1/309 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
18.2%
2/11 • Number of events 3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.95%
6/632 • Number of events 6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.34%
1/293 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.70%
1/143 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.2%
2/93 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.6%
5/309 • Number of events 5 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
3.1%
2/64 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
9.1%
1/11 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Infections and infestations
Nasopharyngitis
|
16.7%
1/6 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.5%
1/40 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
5.6%
1/18 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
6.6%
42/632 • Number of events 56 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
5.1%
15/293 • Number of events 21 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
7.0%
10/143 • Number of events 12 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
4.3%
4/93 • Number of events 4 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
33.3%
1/3 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
4.9%
15/309 • Number of events 17 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
4.7%
3/64 • Number of events 4 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.9%
1/34 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
9.1%
1/11 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Infections and infestations
Onychomycosis
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
11.1%
2/18 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.95%
6/632 • Number of events 8 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.68%
2/293 • Number of events 4 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.4%
2/143 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.2%
2/93 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.5%
1/40 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
5.6%
1/18 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.1%
7/632 • Number of events 7 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
3.2%
3/93 • Number of events 3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.65%
2/309 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.9%
1/34 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Infections and infestations
Paronychia
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
12.5%
5/40 • Number of events 13 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.63%
4/632 • Number of events 4 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.68%
2/293 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.70%
1/143 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
8.6%
8/93 • Number of events 22 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.32%
1/309 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
18.2%
2/11 • Number of events 8 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
3.6%
23/632 • Number of events 23 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.7%
5/293 • Number of events 5 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.1%
3/143 • Number of events 3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.1%
1/93 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.9%
6/309 • Number of events 7 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.6%
1/64 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
8.8%
3/34 • Number of events 3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Infections and infestations
Tracheitis
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
5.6%
1/18 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.16%
1/632 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.70%
1/143 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.1%
1/93 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Infections and infestations
Upper respiratory tract infection
|
16.7%
1/6 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
7.5%
3/40 • Number of events 4 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
11.1%
2/18 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
4.3%
27/632 • Number of events 40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
4.1%
12/293 • Number of events 22 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.4%
2/143 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
5.4%
5/93 • Number of events 6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
3.9%
12/309 • Number of events 13 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
3.1%
2/64 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
8.8%
3/34 • Number of events 3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.5%
1/40 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
5.6%
1/18 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
6.6%
42/632 • Number of events 52 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
4.1%
12/293 • Number of events 13 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.8%
4/143 • Number of events 4 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
6.5%
6/93 • Number of events 6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
5.8%
18/309 • Number of events 25 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
10.9%
7/64 • Number of events 10 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.9%
1/34 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
9.1%
1/11 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
5.0%
2/40 • Number of events 3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.7%
17/632 • Number of events 28 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
3.4%
10/293 • Number of events 12 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
5.4%
5/93 • Number of events 6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
3.6%
11/309 • Number of events 17 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
3.1%
2/64 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
5.0%
2/40 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
5.4%
34/632 • Number of events 52 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.7%
8/293 • Number of events 14 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
4.2%
6/143 • Number of events 9 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
5.4%
5/93 • Number of events 7 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
5.5%
17/309 • Number of events 20 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
18.8%
12/64 • Number of events 13 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Investigations
Amylase increased
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.5%
1/40 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.32%
2/632 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.68%
2/293 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.2%
2/93 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.6%
8/309 • Number of events 8 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
6.2%
4/64 • Number of events 4 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
9.1%
1/11 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.5%
1/40 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
5.6%
1/18 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
5.5%
35/632 • Number of events 45 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
3.4%
10/293 • Number of events 13 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
4.2%
6/143 • Number of events 7 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
6.5%
6/93 • Number of events 9 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
6.5%
20/309 • Number of events 22 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
23.4%
15/64 • Number of events 15 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.5%
1/40 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
3.0%
19/632 • Number of events 20 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.7%
5/293 • Number of events 5 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.8%
4/143 • Number of events 5 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.1%
1/93 • Number of events 3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
3.9%
12/309 • Number of events 16 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
9.4%
6/64 • Number of events 6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.3%
8/632 • Number of events 14 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.4%
4/293 • Number of events 5 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.2%
2/93 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.3%
4/309 • Number of events 6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
4.7%
3/64 • Number of events 5 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
9.1%
1/11 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Skin and subcutaneous tissue disorders
Onychoclasis
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
7.5%
3/40 • Number of events 3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.16%
1/632 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.34%
1/293 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
3.2%
3/93 • Number of events 3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
66.7%
4/6 • Number of events 7 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
12.5%
5/40 • Number of events 5 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
22.2%
4/18 • Number of events 5 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
15.5%
98/632 • Number of events 147 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
15.0%
44/293 • Number of events 66 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
17.5%
25/143 • Number of events 40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
17.2%
16/93 • Number of events 19 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
100.0%
3/3 • Number of events 6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
6.1%
19/309 • Number of events 19 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.6%
1/64 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
8.8%
3/34 • Number of events 3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
18.2%
2/11 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
22.5%
9/40 • Number of events 10 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.63%
4/632 • Number of events 4 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
10.8%
10/93 • Number of events 11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.32%
1/309 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
9.1%
1/11 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
12.5%
5/40 • Number of events 5 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
11.1%
2/18 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
5.4%
34/632 • Number of events 42 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
6.8%
20/293 • Number of events 25 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
4.2%
6/143 • Number of events 6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
10.8%
10/93 • Number of events 10 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
5.2%
16/309 • Number of events 26 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
10.9%
7/64 • Number of events 14 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.9%
1/34 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
27.3%
3/11 • Number of events 3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
32.5%
13/40 • Number of events 17 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
6.8%
43/632 • Number of events 52 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
8.2%
24/293 • Number of events 30 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.70%
1/143 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
21.5%
20/93 • Number of events 24 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
12.3%
38/309 • Number of events 46 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
43.8%
28/64 • Number of events 33 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
36.4%
4/11 • Number of events 4 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
7.5%
3/40 • Number of events 4 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.95%
6/632 • Number of events 6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.68%
2/293 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
3.2%
3/93 • Number of events 4 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
5.0%
2/40 • Number of events 3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/632 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.2%
2/93 • Number of events 3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
5.0%
2/40 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.16%
1/632 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.2%
2/93 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
16.7%
1/6 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.5%
1/40 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.95%
6/632 • Number of events 6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.7%
5/293 • Number of events 5 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.1%
1/93 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
50.0%
1/2 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
17.5%
7/40 • Number of events 11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.1%
7/632 • Number of events 7 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.68%
2/293 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
8.6%
8/93 • Number of events 12 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.97%
3/309 • Number of events 3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.6%
1/64 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.9%
1/34 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
9.1%
1/11 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Skin and subcutaneous tissue disorders
Skin toxicity
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
10.0%
4/40 • Number of events 7 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.63%
4/632 • Number of events 5 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.4%
4/293 • Number of events 5 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
6.5%
6/93 • Number of events 9 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.32%
1/309 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
9.1%
1/11 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Vascular disorders
Hypertension
|
16.7%
1/6 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.5%
1/40 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
5.6%
1/18 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
26.9%
170/632 • Number of events 244 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
16.7%
49/293 • Number of events 70 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
10.5%
15/143 • Number of events 19 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
17.2%
16/93 • Number of events 21 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
20.1%
62/309 • Number of events 79 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
4.7%
3/64 • Number of events 4 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
14.7%
5/34 • Number of events 7 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
9.1%
1/11 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Vascular disorders
Hypotension
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
10.0%
4/40 • Number of events 4 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.6%
10/632 • Number of events 10 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.0%
3/293 • Number of events 3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.70%
1/143 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
8.6%
8/93 • Number of events 8 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.6%
8/309 • Number of events 8 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
4.7%
3/64 • Number of events 3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
18.2%
2/11 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Ear and labyrinth disorders
Auditory meatus external erosion
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/632 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.1%
1/93 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
9.1%
1/11 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Eye disorders
Dry eye
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.79%
5/632 • Number of events 5 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.34%
1/293 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.4%
2/143 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
3.2%
3/93 • Number of events 3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.65%
2/309 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.9%
1/34 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
9.1%
1/11 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Gastrointestinal disorders
Anal haemorrhage
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.4%
9/632 • Number of events 11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.4%
4/293 • Number of events 5 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.2%
2/93 • Number of events 3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.65%
2/309 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.6%
1/64 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
9.1%
1/11 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Gastrointestinal disorders
Cheilitis
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/632 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.1%
1/93 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.97%
3/309 • Number of events 4 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
9.1%
1/11 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.5%
1/40 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
3.0%
19/632 • Number of events 21 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.4%
4/293 • Number of events 4 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
3.2%
3/93 • Number of events 3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.9%
9/309 • Number of events 9 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
4.7%
3/64 • Number of events 3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
9.1%
1/11 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Gastrointestinal disorders
Eructation
|
16.7%
1/6 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.32%
2/632 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.34%
1/293 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Gastrointestinal disorders
Flatulence
|
16.7%
1/6 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.7%
17/632 • Number of events 22 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.68%
2/293 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.70%
1/143 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.2%
2/93 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.9%
6/309 • Number of events 6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.9%
1/34 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
4.0%
25/632 • Number of events 27 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.0%
6/293 • Number of events 8 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.70%
1/143 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
4.3%
4/93 • Number of events 4 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.65%
2/309 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
18.2%
2/11 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.79%
5/632 • Number of events 5 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.34%
1/293 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.2%
2/93 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.65%
2/309 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
9.1%
1/11 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
General disorders
Catheter site pain
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.47%
3/632 • Number of events 4 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.1%
1/93 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.65%
2/309 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
9.1%
1/11 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
General disorders
General physical health deterioration
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.3%
8/632 • Number of events 8 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.2%
2/93 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.32%
1/309 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
9.1%
1/11 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Hepatobiliary disorders
Hepatomegaly
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.47%
3/632 • Number of events 3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.1%
1/93 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
9.1%
1/11 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Infections and infestations
Anal abscess
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/632 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.1%
1/93 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
9.1%
1/11 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Infections and infestations
Catheter site infection
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.47%
3/632 • Number of events 3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.34%
1/293 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.1%
1/93 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
9.1%
1/11 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Infections and infestations
Febrile infection
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.32%
2/632 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.34%
1/293 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.1%
1/93 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.32%
1/309 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.9%
1/34 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
9.1%
1/11 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/632 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.1%
1/93 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
9.1%
1/11 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Infections and infestations
Vascular device infection
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.3%
8/632 • Number of events 8 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.34%
1/293 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.70%
1/143 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.1%
1/93 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.32%
1/309 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
9.1%
1/11 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Infections and infestations
Vulvitis
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/632 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.1%
1/93 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
9.1%
1/11 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Injury, poisoning and procedural complications
Gastrointestinal stoma complication
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.47%
3/632 • Number of events 3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.34%
1/293 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.1%
1/93 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
9.1%
1/11 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.16%
1/632 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.70%
1/143 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.1%
1/93 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
9.1%
1/11 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Injury, poisoning and procedural complications
Sunburn
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.5%
1/40 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.16%
1/632 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.70%
1/143 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
4.3%
4/93 • Number of events 4 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
27.3%
3/11 • Number of events 3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Investigations
Blood potassium decreased
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.16%
1/632 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.34%
1/293 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.1%
1/93 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
9.1%
1/11 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Investigations
Body temperature increased
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/632 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.1%
1/93 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
9.1%
1/11 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Investigations
C-reactive protein increased
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.1%
7/632 • Number of events 8 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.0%
3/293 • Number of events 3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.70%
1/143 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.1%
1/93 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.32%
1/309 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
9.1%
1/11 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Investigations
Cardiac murmur
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/632 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.1%
1/93 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
9.1%
1/11 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Investigations
Neutrophil count decreased
|
33.3%
2/6 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.5%
1/40 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
10.6%
67/632 • Number of events 108 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.4%
7/293 • Number of events 11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.1%
3/143 • Number of events 4 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
14.0%
13/93 • Number of events 17 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
9.1%
28/309 • Number of events 42 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
3.1%
2/64 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
9.1%
1/11 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.47%
3/632 • Number of events 3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.34%
1/293 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.70%
1/143 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.2%
2/93 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
9.1%
1/11 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.5%
1/40 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
4.6%
29/632 • Number of events 43 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.7%
5/293 • Number of events 6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.4%
2/143 • Number of events 5 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.1%
1/93 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
5.2%
16/309 • Number of events 20 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.6%
1/64 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.1%
7/632 • Number of events 9 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.4%
4/293 • Number of events 5 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.70%
1/143 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.1%
1/93 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.97%
3/309 • Number of events 3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.9%
1/34 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
9.1%
1/11 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.1%
7/632 • Number of events 7 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.2%
2/93 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.3%
4/309 • Number of events 4 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.6%
1/64 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
18.2%
2/11 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.5%
1/40 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.32%
2/632 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.4%
2/143 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.2%
2/93 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
9.1%
1/11 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Musculoskeletal and connective tissue disorders
Osteoporotic fracture
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/632 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.1%
1/93 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
9.1%
1/11 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
16.7%
1/6 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.79%
5/632 • Number of events 5 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.34%
1/293 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.32%
1/309 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.9%
1/34 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.16%
1/632 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.34%
1/293 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.1%
1/93 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
9.1%
1/11 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Nervous system disorders
Ageusia
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.32%
2/632 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.1%
1/93 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.97%
3/309 • Number of events 4 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.9%
1/34 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
9.1%
1/11 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Nervous system disorders
Taste disorder
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.1%
13/632 • Number of events 13 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.34%
1/293 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.70%
1/143 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
4.3%
4/93 • Number of events 4 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.32%
1/309 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
9.1%
1/11 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Product Issues
Device occlusion
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.16%
1/632 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.70%
1/143 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.2%
2/93 • Number of events 3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.97%
3/309 • Number of events 3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
9.1%
1/11 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Psychiatric disorders
Depression
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.5%
1/40 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.9%
12/632 • Number of events 13 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.0%
3/293 • Number of events 3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
3.5%
5/143 • Number of events 5 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
3.2%
3/93 • Number of events 3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.65%
2/309 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
18.2%
2/11 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/632 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.1%
1/93 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
9.1%
1/11 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.5%
1/40 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/632 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.2%
2/93 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
9.1%
1/11 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.5%
1/40 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.47%
3/632 • Number of events 3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.70%
1/143 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
5.4%
5/93 • Number of events 7 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
27.3%
3/11 • Number of events 4 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.32%
2/632 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.34%
1/293 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.1%
1/93 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
9.1%
1/11 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/632 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.1%
1/93 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
9.1%
1/11 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/632 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.1%
1/93 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
9.1%
1/11 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Skin and subcutaneous tissue disorders
Erythema nodosum
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/632 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.1%
1/93 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
9.1%
1/11 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Skin and subcutaneous tissue disorders
Hair texture abnormal
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/632 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.1%
1/93 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
9.1%
1/11 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Skin and subcutaneous tissue disorders
Hand dermatitis
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.16%
1/632 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.34%
1/293 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.1%
1/93 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
9.1%
1/11 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.5%
1/40 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.3%
8/632 • Number of events 12 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.4%
4/293 • Number of events 6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.2%
2/93 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.6%
5/309 • Number of events 6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
4.7%
3/64 • Number of events 3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
9.1%
1/11 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Skin and subcutaneous tissue disorders
Rosacea
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/632 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.1%
1/93 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
9.1%
1/11 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Vascular disorders
Phlebitis
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.5%
1/40 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.95%
6/632 • Number of events 6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.2%
2/93 • Number of events 3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.65%
2/309 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
9.1%
1/11 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Injury, poisoning and procedural complications
Stoma site pain
|
16.7%
1/6 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.47%
3/632 • Number of events 4 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.34%
1/293 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
16.7%
1/6 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.63%
4/632 • Number of events 4 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.0%
3/293 • Number of events 3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.1%
1/93 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.32%
1/309 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Investigations
Blood lactate dehydrogenase increased
|
16.7%
1/6 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.1%
7/632 • Number of events 8 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.0%
3/293 • Number of events 3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.4%
2/143 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.1%
1/93 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.3%
4/309 • Number of events 4 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
3.1%
2/64 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour associated fever
|
16.7%
1/6 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/632 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/93 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
33.3%
2/6 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
20.0%
8/40 • Number of events 10 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
20.6%
130/632 • Number of events 171 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
8.2%
24/293 • Number of events 26 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
9.8%
14/143 • Number of events 15 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
21.5%
20/93 • Number of events 26 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
15.2%
47/309 • Number of events 55 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
17.2%
11/64 • Number of events 12 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.9%
1/34 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
18.2%
2/11 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
5.0%
2/40 • Number of events 3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.6%
10/632 • Number of events 11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.0%
3/293 • Number of events 3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
3.2%
3/93 • Number of events 5 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
3.6%
11/309 • Number of events 12 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.6%
1/64 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Investigations
White blood cell count decreased
|
16.7%
1/6 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.5%
16/632 • Number of events 23 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.34%
1/293 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.70%
1/143 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.2%
2/93 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
33.3%
1/3 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.9%
6/309 • Number of events 8 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
3.1%
2/64 • Number of events 4 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.7%
11/632 • Number of events 11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.4%
4/293 • Number of events 4 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.2%
2/93 • Number of events 3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.97%
3/309 • Number of events 4 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
3.1%
2/64 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
9.1%
1/11 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Metabolism and nutrition disorders
Food craving
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
5.6%
1/18 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/632 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.1%
1/93 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
5.6%
1/18 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.7%
17/632 • Number of events 23 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.68%
2/293 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.4%
2/143 • Number of events 4 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.1%
1/93 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.9%
6/309 • Number of events 8 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.6%
1/64 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
5.0%
2/40 • Number of events 3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
5.6%
1/18 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.8%
18/632 • Number of events 37 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.7%
5/293 • Number of events 10 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
4.2%
6/143 • Number of events 10 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
4.3%
4/93 • Number of events 5 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.3%
7/309 • Number of events 10 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
3.1%
2/64 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
16.7%
1/6 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
7.5%
3/40 • Number of events 6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
5.6%
1/18 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
10.8%
68/632 • Number of events 91 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.0%
6/293 • Number of events 7 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
5.6%
8/143 • Number of events 9 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
14.0%
13/93 • Number of events 20 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
33.3%
1/3 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
5.2%
16/309 • Number of events 18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
6.2%
4/64 • Number of events 4 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.9%
1/34 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
18.2%
2/11 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
15.0%
6/40 • Number of events 6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.4%
9/632 • Number of events 9 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.4%
4/293 • Number of events 4 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
7.5%
7/93 • Number of events 9 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.9%
6/309 • Number of events 7 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
9.1%
1/11 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
5.0%
2/40 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.6%
10/632 • Number of events 10 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.68%
2/293 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.1%
3/143 • Number of events 3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
3.2%
3/93 • Number of events 3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.9%
6/309 • Number of events 8 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.7%
1/6 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
45.0%
18/40 • Number of events 30 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
16.7%
3/18 • Number of events 5 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
11.7%
74/632 • Number of events 100 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
17.1%
50/293 • Number of events 67 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
5.6%
8/143 • Number of events 10 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
30.1%
28/93 • Number of events 48 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
6.1%
19/309 • Number of events 22 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
12.5%
8/64 • Number of events 8 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
8.8%
3/34 • Number of events 5 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
45.5%
5/11 • Number of events 5 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
12.5%
5/40 • Number of events 5 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
11.1%
2/18 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
7.1%
45/632 • Number of events 59 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
7.5%
22/293 • Number of events 32 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
6.3%
9/143 • Number of events 9 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
16.1%
15/93 • Number of events 17 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
5.2%
16/309 • Number of events 17 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
7.8%
5/64 • Number of events 5 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
8.8%
3/34 • Number of events 3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
27.3%
3/11 • Number of events 4 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
5.6%
1/18 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.6%
10/632 • Number of events 10 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.0%
6/293 • Number of events 6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.1%
1/93 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.97%
3/309 • Number of events 4 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
16.7%
1/6 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
5.0%
2/40 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.4%
15/632 • Number of events 15 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.7%
5/293 • Number of events 5 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
4.3%
4/93 • Number of events 4 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
33.3%
1/3 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.3%
4/309 • Number of events 4 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.6%
1/64 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
5.6%
1/18 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.16%
1/632 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.34%
1/293 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.1%
1/93 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
5.0%
2/40 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.6%
10/632 • Number of events 13 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.7%
5/293 • Number of events 6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.4%
2/143 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.2%
2/93 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
15.0%
6/40 • Number of events 8 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
5.6%
1/18 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
4.4%
28/632 • Number of events 34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
5.1%
15/293 • Number of events 17 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.1%
3/143 • Number of events 3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
14.0%
13/93 • Number of events 18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
5.8%
18/309 • Number of events 23 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
7.8%
5/64 • Number of events 5 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
5.9%
2/34 • Number of events 3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
9.1%
1/11 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
5.6%
1/18 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.47%
3/632 • Number of events 3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.68%
2/293 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.70%
1/143 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.1%
1/93 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
17.5%
7/40 • Number of events 10 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
6.3%
40/632 • Number of events 50 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
4.4%
13/293 • Number of events 18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
5.6%
8/143 • Number of events 9 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
8.6%
8/93 • Number of events 11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
3.9%
12/309 • Number of events 14 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
7.8%
5/64 • Number of events 6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
5.9%
2/34 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
10.0%
4/40 • Number of events 4 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
5.6%
1/18 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
4.6%
29/632 • Number of events 35 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.0%
6/293 • Number of events 7 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.70%
1/143 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
6.5%
6/93 • Number of events 11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
3.9%
12/309 • Number of events 12 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
6.2%
4/64 • Number of events 4 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.9%
1/34 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Nervous system disorders
Dysgeusia
|
16.7%
1/6 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
10.0%
4/40 • Number of events 4 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
9.3%
59/632 • Number of events 71 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.7%
8/293 • Number of events 8 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.1%
3/143 • Number of events 3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
9.7%
9/93 • Number of events 11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
6.8%
21/309 • Number of events 26 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
9.1%
1/11 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Nervous system disorders
Headache
|
16.7%
1/6 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
5.0%
2/40 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
11.6%
73/632 • Number of events 179 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
8.2%
24/293 • Number of events 83 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
3.5%
5/143 • Number of events 15 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
7.5%
7/93 • Number of events 10 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
9.1%
28/309 • Number of events 50 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
9.4%
6/64 • Number of events 8 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
8.8%
3/34 • Number of events 5 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Nervous system disorders
Neuropathy peripheral
|
33.3%
2/6 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.5%
1/40 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
16.3%
103/632 • Number of events 145 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
6.1%
18/293 • Number of events 21 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
6.3%
9/143 • Number of events 9 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
10.8%
10/93 • Number of events 11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
18.4%
57/309 • Number of events 84 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.6%
1/64 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
14.7%
5/34 • Number of events 5 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Nervous system disorders
Neurotoxicity
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
7.5%
3/40 • Number of events 3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
3.5%
22/632 • Number of events 31 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.68%
2/293 • Number of events 3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.4%
2/143 • Number of events 3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
9.7%
9/93 • Number of events 15 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
8.7%
27/309 • Number of events 46 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
4.7%
3/64 • Number of events 3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.9%
1/34 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Nervous system disorders
Paraesthesia
|
33.3%
2/6 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
10.0%
4/40 • Number of events 4 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
14.7%
93/632 • Number of events 125 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
6.1%
18/293 • Number of events 21 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
7.0%
10/143 • Number of events 11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
21.5%
20/93 • Number of events 29 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
13.9%
43/309 • Number of events 57 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.6%
1/64 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.9%
1/34 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
50.0%
3/6 • Number of events 7 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
10.0%
4/40 • Number of events 5 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
5.6%
1/18 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
35.1%
222/632 • Number of events 357 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
10.9%
32/293 • Number of events 38 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
10.5%
15/143 • Number of events 16 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
28.0%
26/93 • Number of events 33 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
18.8%
58/309 • Number of events 91 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
4.7%
3/64 • Number of events 6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
11.8%
4/34 • Number of events 4 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Nervous system disorders
Polyneuropathy
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
5.6%
1/18 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
4.1%
26/632 • Number of events 35 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.0%
6/293 • Number of events 6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.70%
1/143 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
3.2%
3/93 • Number of events 3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.9%
9/309 • Number of events 12 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Nervous system disorders
Restless legs syndrome
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
5.6%
1/18 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.16%
1/632 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.70%
1/143 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
3.2%
3/93 • Number of events 3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.32%
1/309 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
9.1%
1/11 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Nervous system disorders
Sensory loss
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
5.6%
1/18 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/632 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.1%
1/93 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
5.0%
2/40 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.79%
5/632 • Number of events 7 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.4%
4/293 • Number of events 5 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
3.2%
3/93 • Number of events 3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Psychiatric disorders
Anxiety
|
16.7%
1/6 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.5%
1/40 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
5.6%
1/18 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
3.0%
19/632 • Number of events 19 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.4%
4/293 • Number of events 4 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.70%
1/143 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
6.5%
6/93 • Number of events 7 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.9%
9/309 • Number of events 9 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.6%
1/64 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
5.0%
2/40 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
5.6%
1/18 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
6.0%
38/632 • Number of events 40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
3.4%
10/293 • Number of events 10 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.1%
3/143 • Number of events 3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
15.1%
14/93 • Number of events 14 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
3.9%
12/309 • Number of events 13 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
4.7%
3/64 • Number of events 3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
18.2%
2/11 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
5.6%
1/18 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
3.2%
20/632 • Number of events 21 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.68%
2/293 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.70%
1/143 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
3.2%
3/93 • Number of events 3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
3.2%
10/309 • Number of events 12 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
3.1%
2/64 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.5%
1/40 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
6.3%
40/632 • Number of events 56 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
5.8%
17/293 • Number of events 25 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.8%
4/143 • Number of events 4 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.2%
2/93 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.3%
7/309 • Number of events 12 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.6%
1/64 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
5.9%
2/34 • Number of events 4 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.7%
1/6 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
12.5%
5/40 • Number of events 6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
16.7%
3/18 • Number of events 3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
12.2%
77/632 • Number of events 95 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
10.2%
30/293 • Number of events 39 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
6.3%
9/143 • Number of events 11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
11.8%
11/93 • Number of events 12 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
8.7%
27/309 • Number of events 31 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
10.9%
7/64 • Number of events 7 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
8.8%
3/34 • Number of events 3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.5%
1/40 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
5.6%
1/18 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
7.4%
47/632 • Number of events 61 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
5.1%
15/293 • Number of events 18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.1%
3/143 • Number of events 3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
6.5%
6/93 • Number of events 7 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
4.5%
14/309 • Number of events 14 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.6%
1/64 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
16.7%
1/6 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
5.0%
2/40 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
11.1%
2/18 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
7.4%
47/632 • Number of events 51 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
4.1%
12/293 • Number of events 12 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.1%
3/143 • Number of events 3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
8.6%
8/93 • Number of events 11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
33.3%
1/3 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
6.5%
20/309 • Number of events 21 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
3.1%
2/64 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.9%
1/34 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
18.2%
2/11 • Number of events 3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
50.0%
3/6 • Number of events 3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
10.0%
4/40 • Number of events 4 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
5.6%
1/18 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
19.1%
121/632 • Number of events 157 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
7.8%
23/293 • Number of events 29 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
11.2%
16/143 • Number of events 20 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
19.4%
18/93 • Number of events 24 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
100.0%
2/2 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
19.7%
61/309 • Number of events 70 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
9.4%
6/64 • Number of events 6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
8.8%
3/34 • Number of events 4 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
27.3%
3/11 • Number of events 3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
5.6%
1/18 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
3.2%
20/632 • Number of events 26 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.70%
1/143 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.1%
1/93 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.6%
8/309 • Number of events 9 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
5.6%
1/18 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.79%
5/632 • Number of events 5 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.68%
2/293 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.2%
2/93 • Number of events 3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.32%
1/309 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.9%
1/34 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
9.1%
1/11 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal ulcer
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
5.6%
1/18 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/632 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.1%
1/93 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
16.7%
1/6 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.5%
1/40 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
3.2%
20/632 • Number of events 27 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.0%
6/293 • Number of events 9 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.1%
3/143 • Number of events 4 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.2%
2/93 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
33.3%
1/3 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.6%
5/309 • Number of events 5 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.6%
1/64 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.5%
1/40 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
5.6%
1/18 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
3.0%
19/632 • Number of events 19 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.0%
3/293 • Number of events 3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.70%
1/143 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
6.5%
6/93 • Number of events 7 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.6%
5/309 • Number of events 5 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.9%
1/34 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
16.7%
1/6 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.5%
1/40 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
11.1%
2/18 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
10.0%
63/632 • Number of events 64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.7%
8/293 • Number of events 8 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.4%
2/143 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
9.7%
9/93 • Number of events 10 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
6.1%
19/309 • Number of events 19 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.9%
1/34 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
5.6%
1/18 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.63%
4/632 • Number of events 5 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.0%
3/293 • Number of events 3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.70%
1/143 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.2%
2/93 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.32%
1/309 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.6%
1/64 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
27.5%
11/40 • Number of events 13 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.6%
10/632 • Number of events 11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.4%
4/293 • Number of events 4 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
12.9%
12/93 • Number of events 14 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
6.5%
20/309 • Number of events 23 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
28.1%
18/64 • Number of events 20 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
5.9%
2/34 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
9.1%
1/11 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
5.6%
1/18 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/632 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.1%
1/93 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
16.7%
1/6 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
30.0%
12/40 • Number of events 16 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
16.7%
3/18 • Number of events 3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
7.0%
44/632 • Number of events 54 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
6.1%
18/293 • Number of events 21 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.1%
3/143 • Number of events 6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
22.6%
21/93 • Number of events 27 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
33.3%
1/3 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
6.5%
20/309 • Number of events 20 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
9.4%
6/64 • Number of events 6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.9%
1/34 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
27.3%
3/11 • Number of events 3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
5.0%
2/40 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/18 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.63%
4/632 • Number of events 4 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.68%
2/293 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/143 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.2%
2/93 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/6 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
20.0%
8/40 • Number of events 11 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
5.6%
1/18 • Number of events 4 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
3.3%
21/632 • Number of events 22 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
3.8%
11/293 • Number of events 12 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.4%
2/143 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
11.8%
11/93 • Number of events 19 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.3%
4/309 • Number of events 4 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
1.6%
1/64 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
18.2%
2/11 • Number of events 4 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
|
Skin and subcutaneous tissue disorders
Nail ridging
|
16.7%
1/6 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/40 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
5.6%
1/18 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.47%
3/632 • Number of events 3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/293 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.1%
3/143 • Number of events 3 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
2.2%
2/93 • Number of events 2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
33.3%
1/3 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/2 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/309 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/64 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
0.00%
0/34 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
9.1%
1/11 • Number of events 1 • From baseline until end of study (up to 5 years)
All-cause mortality was based on the intent-to-treat (ITT) population, which included all participants randomized in the study. Serious Adverse Events and Other Adverse Events were based on the safety population, which included all participants who received an intervention during the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER