Trial Outcomes & Findings for Study of Semaglutide, and Cilofexor/Firsocostat, Alone and in Combination, in Adults With Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH) (NCT NCT04971785)
NCT ID: NCT04971785
Last Updated: 2025-11-26
Results Overview
Fibrosis improvement was defined as ≥ 1-stage decrease from baseline in fibrosis according to the NASH clinical research network (CRN) classification. Worsening of NASH was defined as ≥ 1-point increase from baseline in hepatocellular ballooning or lobular inflammation. Clopper-Pearson method was used in outcome measure analysis in each arm. Percentages were rounded-off.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
457 participants
Primary outcome timeframe
Week 72
Results posted on
2025-11-26
Participant Flow
Participants were enrolled at study sites in the United States, Canada, France, Japan, Australia and Spain.
1595 participants were screened.
Participant milestones
| Measure |
SEMA + CILO/FIR FDC
Participants received semaglutide (SEMA) 3.0 mg/mL subcutaneous (SC) injection once weekly and cilofexor and firsocostat (CILO/FIR) 30 mg/20 mg fixed-dose combination (FDC) tablet orally, once daily up to 72 weeks.
|
SEMA + PTM CILO/FIR
Participants received SEMA 3.0 mg/mL SC injection, once weekly and Placebo-To-Match (PTM) CILO/FIR FDC tablet orally, once daily up to 72 weeks.
|
PTM SEMA + CILO/FIR FDC
Participants received PTM SEMA SC injection, once weekly and CILO/FIR 30 mg/20 mg FDC tablet orally, once daily up to 72 weeks.
|
PTM SEMA + PTM CILO/FIR
Participants received PTM SEMA SC injection, once weekly and PTM CILO/FIR FDC tablet orally, once daily up to 72 weeks.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
125
|
124
|
123
|
85
|
|
Overall Study
COMPLETED
|
103
|
104
|
91
|
65
|
|
Overall Study
NOT COMPLETED
|
22
|
20
|
32
|
20
|
Reasons for withdrawal
| Measure |
SEMA + CILO/FIR FDC
Participants received semaglutide (SEMA) 3.0 mg/mL subcutaneous (SC) injection once weekly and cilofexor and firsocostat (CILO/FIR) 30 mg/20 mg fixed-dose combination (FDC) tablet orally, once daily up to 72 weeks.
|
SEMA + PTM CILO/FIR
Participants received SEMA 3.0 mg/mL SC injection, once weekly and Placebo-To-Match (PTM) CILO/FIR FDC tablet orally, once daily up to 72 weeks.
|
PTM SEMA + CILO/FIR FDC
Participants received PTM SEMA SC injection, once weekly and CILO/FIR 30 mg/20 mg FDC tablet orally, once daily up to 72 weeks.
|
PTM SEMA + PTM CILO/FIR
Participants received PTM SEMA SC injection, once weekly and PTM CILO/FIR FDC tablet orally, once daily up to 72 weeks.
|
|---|---|---|---|---|
|
Overall Study
Withdrew Consent
|
5
|
5
|
17
|
7
|
|
Overall Study
Adverse Event
|
7
|
8
|
6
|
3
|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
6
|
7
|
|
Overall Study
Protocol Violation
|
3
|
1
|
1
|
2
|
|
Overall Study
Investigator's Discretion
|
3
|
1
|
1
|
0
|
|
Overall Study
Randomized but Never Treated
|
1
|
2
|
0
|
1
|
|
Overall Study
Death
|
0
|
1
|
1
|
0
|
|
Overall Study
Site Terminated by Sponsor
|
1
|
1
|
0
|
0
|
Baseline Characteristics
Study of Semaglutide, and Cilofexor/Firsocostat, Alone and in Combination, in Adults With Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH)
Baseline characteristics by cohort
| Measure |
SEMA + CILO/FIR FDC
n=124 Participants
Participants received semaglutide (SEMA) 3.0 mg/mL subcutaneous (SC) injection once weekly and cilofexor and firsocostat (CILO/FIR) 30 mg/20 mg fixed-dose combination (FDC) tablet orally, once daily up to 72 weeks.
|
SEMA + PTM CILO/FIR
n=122 Participants
Participants received SEMA 3.0 mg/mL SC injection, once weekly and Placebo-To-Match (PTM) CILO/FIR FDC tablet orally, once daily up to 72 weeks.
|
PTM SEMA + CILO/FIR FDC
n=123 Participants
Participants received PTM SEMA SC injection, once weekly and CILO/FIR 30 mg/20 mg FDC tablet orally, once daily up to 72 weeks.
|
PTM SEMA + PTM CILO/FIR
n=84 Participants
Participants received PTM SEMA SC injection, once weekly and PTM CILO/FIR FDC tablet orally, once daily up to 72 weeks.
|
Total
n=453 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=9 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=78 Participants
|
0 Participants
n=16 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
72 Participants
n=9 Participants
|
73 Participants
n=32 Participants
|
67 Participants
n=18 Participants
|
44 Participants
n=78 Participants
|
256 Participants
n=16 Participants
|
|
Age, Categorical
>=65 years
|
52 Participants
n=9 Participants
|
49 Participants
n=32 Participants
|
56 Participants
n=18 Participants
|
40 Participants
n=78 Participants
|
197 Participants
n=16 Participants
|
|
Age, Continuous
|
61 years
STANDARD_DEVIATION 10.4 • n=9 Participants
|
61 years
STANDARD_DEVIATION 9.2 • n=32 Participants
|
62 years
STANDARD_DEVIATION 9.5 • n=18 Participants
|
63 years
STANDARD_DEVIATION 9.1 • n=78 Participants
|
62 years
STANDARD_DEVIATION 9.6 • n=16 Participants
|
|
Sex: Female, Male
Female
|
83 Participants
n=9 Participants
|
85 Participants
n=32 Participants
|
74 Participants
n=18 Participants
|
50 Participants
n=78 Participants
|
292 Participants
n=16 Participants
|
|
Sex: Female, Male
Male
|
41 Participants
n=9 Participants
|
37 Participants
n=32 Participants
|
49 Participants
n=18 Participants
|
34 Participants
n=78 Participants
|
161 Participants
n=16 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
28 Participants
n=9 Participants
|
23 Participants
n=32 Participants
|
30 Participants
n=18 Participants
|
19 Participants
n=78 Participants
|
100 Participants
n=16 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
95 Participants
n=9 Participants
|
99 Participants
n=32 Participants
|
90 Participants
n=18 Participants
|
62 Participants
n=78 Participants
|
346 Participants
n=16 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=9 Participants
|
0 Participants
n=32 Participants
|
3 Participants
n=18 Participants
|
3 Participants
n=78 Participants
|
7 Participants
n=16 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=9 Participants
|
1 Participants
n=32 Participants
|
1 Participants
n=18 Participants
|
2 Participants
n=78 Participants
|
7 Participants
n=16 Participants
|
|
Race (NIH/OMB)
Asian
|
11 Participants
n=9 Participants
|
9 Participants
n=32 Participants
|
15 Participants
n=18 Participants
|
3 Participants
n=78 Participants
|
38 Participants
n=16 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=78 Participants
|
0 Participants
n=16 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=9 Participants
|
1 Participants
n=32 Participants
|
1 Participants
n=18 Participants
|
5 Participants
n=78 Participants
|
9 Participants
n=16 Participants
|
|
Race (NIH/OMB)
White
|
100 Participants
n=9 Participants
|
108 Participants
n=32 Participants
|
98 Participants
n=18 Participants
|
66 Participants
n=78 Participants
|
372 Participants
n=16 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=9 Participants
|
2 Participants
n=32 Participants
|
3 Participants
n=18 Participants
|
4 Participants
n=78 Participants
|
14 Participants
n=16 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=9 Participants
|
1 Participants
n=32 Participants
|
5 Participants
n=18 Participants
|
4 Participants
n=78 Participants
|
13 Participants
n=16 Participants
|
|
Region of Enrollment
United States
|
95 Participants
n=9 Participants
|
99 Participants
n=32 Participants
|
88 Participants
n=18 Participants
|
63 Participants
n=78 Participants
|
345 Participants
n=16 Participants
|
|
Region of Enrollment
Canada
|
7 Participants
n=9 Participants
|
7 Participants
n=32 Participants
|
12 Participants
n=18 Participants
|
6 Participants
n=78 Participants
|
32 Participants
n=16 Participants
|
|
Region of Enrollment
France
|
5 Participants
n=9 Participants
|
5 Participants
n=32 Participants
|
9 Participants
n=18 Participants
|
10 Participants
n=78 Participants
|
29 Participants
n=16 Participants
|
|
Region of Enrollment
Japan
|
4 Participants
n=9 Participants
|
6 Participants
n=32 Participants
|
6 Participants
n=18 Participants
|
1 Participants
n=78 Participants
|
17 Participants
n=16 Participants
|
|
Region of Enrollment
Australia
|
6 Participants
n=9 Participants
|
2 Participants
n=32 Participants
|
6 Participants
n=18 Participants
|
2 Participants
n=78 Participants
|
16 Participants
n=16 Participants
|
|
Region of Enrollment
Spain
|
7 Participants
n=9 Participants
|
3 Participants
n=32 Participants
|
2 Participants
n=18 Participants
|
2 Participants
n=78 Participants
|
14 Participants
n=16 Participants
|
PRIMARY outcome
Timeframe: Week 72Population: Participants in the Full Analysis Set in SEMA + CILO/FIR FDC and PTM SEMA + PTM CILO/FIR were analyzed. The Full Analysis Set included all randomized participants who received at least 1 dose of study drug.
Fibrosis improvement was defined as ≥ 1-stage decrease from baseline in fibrosis according to the NASH clinical research network (CRN) classification. Worsening of NASH was defined as ≥ 1-point increase from baseline in hepatocellular ballooning or lobular inflammation. Clopper-Pearson method was used in outcome measure analysis in each arm. Percentages were rounded-off.
Outcome measures
| Measure |
SEMA + CILO/FIR FDC
n=124 Participants
Participants received semaglutide (SEMA) 3.0 mg/mL subcutaneous (SC) injection once weekly and cilofexor and firsocostat (CILO/FIR) 30 mg/20 mg fixed-dose combination (FDC) tablet orally, once daily up to 72 weeks.
|
PTM SEMA + PTM CILO/FIR
n=84 Participants
Participants received PTM SEMA SC injection, once weekly and PTM CILO/FIR FDC tablet orally, once daily up to 72 weeks.
|
|---|---|---|
|
Percentage of Participants Who Achieved ≥ 1-Stage Improvement in Fibrosis Without Worsening of Nonalcoholic Steatohepatitis (NASH) at Week 72 in Semaglutide (SEMA) + Cilofexor/Firsocostat (CILO/FIR) Fixed Dose Combination (FDC) Versus Placebo Groups
|
13.7 percentage of participants
Interval 8.2 to 21.0
|
8.3 percentage of participants
Interval 3.4 to 16.4
|
SECONDARY outcome
Timeframe: Week 72Population: Participants in the Full Analysis Set in SEMA + CILO/FIR and SEMA + PTM CILO/FIR were analyzed.
Fibrosis improvement was defined as ≥ 1-stage decrease from baseline in fibrosis according to the NASH CRN classification. Worsening of NASH was defined as ≥ 1-point increase from baseline in hepatocellular ballooning or lobular inflammation. Clopper-Pearson method was used in outcome measure analysis in each arm. Percentages were rounded-off.
Outcome measures
| Measure |
SEMA + CILO/FIR FDC
n=124 Participants
Participants received semaglutide (SEMA) 3.0 mg/mL subcutaneous (SC) injection once weekly and cilofexor and firsocostat (CILO/FIR) 30 mg/20 mg fixed-dose combination (FDC) tablet orally, once daily up to 72 weeks.
|
PTM SEMA + PTM CILO/FIR
n=122 Participants
Participants received PTM SEMA SC injection, once weekly and PTM CILO/FIR FDC tablet orally, once daily up to 72 weeks.
|
|---|---|---|
|
Percentage of Participants Who Achieved ≥1-Stage Improvement in Fibrosis Without Worsening of NASH at Week 72 in SEMA + CILO/FIR FDC Versus SEMA Alone
|
13.7 percentage of participants
Interval 8.2 to 21.0
|
15.6 percentage of participants
Interval 9.6 to 23.2
|
SECONDARY outcome
Timeframe: Week 72Population: Participants in the Full Analysis Set in SEMA + CILO/FIR FDC and PTM SEMA + PTM CILO/FIR with available data were analyzed.
NASH resolution is defined as lobular inflammation of 0 or 1 and hepatocellular ballooning of 0. Worsening in fibrosis was defined as a change in fibrosis worsening stage as per NASH CRN criteria. Clopper-Pearson method was used in outcome measure analysis in each arm. Percentages were rounded-off.
Outcome measures
| Measure |
SEMA + CILO/FIR FDC
n=82 Participants
Participants received semaglutide (SEMA) 3.0 mg/mL subcutaneous (SC) injection once weekly and cilofexor and firsocostat (CILO/FIR) 30 mg/20 mg fixed-dose combination (FDC) tablet orally, once daily up to 72 weeks.
|
PTM SEMA + PTM CILO/FIR
n=49 Participants
Participants received PTM SEMA SC injection, once weekly and PTM CILO/FIR FDC tablet orally, once daily up to 72 weeks.
|
|---|---|---|
|
Percentage of Participants With NASH Resolution Without Worsening in Fibrosis at Week 72 in SEMA + CILO/FIR FDC Versus Placebo Groups
|
57.3 percentage of participants
Interval 45.9 to 68.2
|
22.4 percentage of participants
Interval 11.8 to 36.6
|
SECONDARY outcome
Timeframe: Week 72Population: Participants in the Full Analysis Set in SEMA + CILO/FIR FDC and PTM SEMA + CILO/FIR FDC with available data were analyzed.
NASH resolution is defined as lobular inflammation of 0 or 1 and hepatocellular ballooning of 0. Worsening in fibrosis was defined as a change in fibrosis worsening stage as per NASH CRN criteria. Clopper-Pearson method was used in outcome measure analysis in each arm. Percentages were rounded-off.
Outcome measures
| Measure |
SEMA + CILO/FIR FDC
n=82 Participants
Participants received semaglutide (SEMA) 3.0 mg/mL subcutaneous (SC) injection once weekly and cilofexor and firsocostat (CILO/FIR) 30 mg/20 mg fixed-dose combination (FDC) tablet orally, once daily up to 72 weeks.
|
PTM SEMA + PTM CILO/FIR
n=88 Participants
Participants received PTM SEMA SC injection, once weekly and PTM CILO/FIR FDC tablet orally, once daily up to 72 weeks.
|
|---|---|---|
|
Percentage of Participants With NASH Resolution Without Worsening in Fibrosis In Participants Treated With SEMA + CILO/FIR FDC Versus CILO/FIR Alone Groups
|
57.3 percentage of participants
Interval 45.9 to 68.2
|
31.8 percentage of participants
Interval 22.3 to 42.6
|
Adverse Events
SEMA + CILO/FIR FDC
Serious events: 17 serious events
Other events: 101 other events
Deaths: 0 deaths
SEMA + PTM CILO/FIR
Serious events: 13 serious events
Other events: 97 other events
Deaths: 1 deaths
PTM SEMA + CILO/FIR FDC
Serious events: 18 serious events
Other events: 85 other events
Deaths: 1 deaths
PTM SEMA + PTM CILO/FIR
Serious events: 11 serious events
Other events: 60 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SEMA + CILO/FIR FDC
n=124 participants at risk
Participants received semaglutide (SEMA) 3.0 mg/mL subcutaneous (SC) injection once weekly and cilofexor and firsocostat (CILO/FIR) 30 mg/20 mg fixed-dose combination (FDC) tablet orally, once daily up to 72 weeks.
|
SEMA + PTM CILO/FIR
n=122 participants at risk
Participants received SEMA 3.0 mg/mL SC injection, once weekly and Placebo-To-Match (PTM) CILO/FIR FDC tablet orally, once daily up to 72 weeks.
|
PTM SEMA + CILO/FIR FDC
n=123 participants at risk
Participants received PTM SEMA SC injection, once weekly and CILO/FIR 30 mg/20 mg FDC tablet orally, once daily up to 72 weeks.
|
PTM SEMA + PTM CILO/FIR
n=84 participants at risk
Participants received PTM SEMA SC injection, once weekly and PTM CILO/FIR FDC tablet orally, once daily up to 72 weeks.
|
|---|---|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.81%
1/124 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/122 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/123 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/84 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Angina pectoris
|
0.81%
1/124 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/122 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/123 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/84 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Congenital, familial and genetic disorders
Atrial septal defect
|
0.81%
1/124 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/122 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/123 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/84 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/124 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/122 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/123 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
1.2%
1/84 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Proctitis
|
0.00%
0/124 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.82%
1/122 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/123 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/84 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/124 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.82%
1/122 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/123 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/84 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/124 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/122 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.81%
1/123 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/84 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
General disorders
Asthenia
|
0.00%
0/124 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.82%
1/122 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/123 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/84 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
General disorders
Prosthetic cardiac valve stenosis
|
0.00%
0/124 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/122 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/123 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
1.2%
1/84 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.81%
1/124 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/122 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/123 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/84 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.00%
0/124 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/122 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.81%
1/123 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/84 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Steatohepatitis
|
0.00%
0/124 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/122 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.81%
1/123 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/84 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Abdominal wall abscess
|
0.00%
0/124 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/122 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.81%
1/123 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/84 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Appendicitis
|
0.81%
1/124 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/122 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/123 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/84 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Covid-19
|
0.00%
0/124 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/122 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.81%
1/123 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/84 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Covid-19 pneumonia
|
0.00%
0/124 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/122 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
1.6%
2/123 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/84 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/124 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/122 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.81%
1/123 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/84 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Diverticulitis intestinal perforated
|
0.00%
0/124 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/122 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/123 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
1.2%
1/84 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Large intestine infection
|
0.00%
0/124 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/122 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.81%
1/123 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/84 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Localised infection
|
0.00%
0/124 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.82%
1/122 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/123 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/84 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/124 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.82%
1/122 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.81%
1/123 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/84 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Post procedural cellulitis
|
0.00%
0/124 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/122 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.81%
1/123 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/84 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Pyelonephritis
|
0.81%
1/124 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/122 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/123 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/84 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Salmonellosis
|
0.00%
0/124 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/122 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.81%
1/123 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/84 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Sepsis
|
0.00%
0/124 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/122 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.81%
1/123 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
1.2%
1/84 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/124 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/122 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.81%
1/123 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/84 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Heat exhaustion
|
0.81%
1/124 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/122 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/123 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/84 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/124 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/122 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/123 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
1.2%
1/84 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.81%
1/124 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/122 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/123 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/84 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/124 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.82%
1/122 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/123 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/84 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Shoulder fracture
|
0.00%
0/124 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.82%
1/122 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/123 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/84 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.81%
1/124 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/122 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/123 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/84 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/124 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.82%
1/122 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/123 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/84 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/124 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/122 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.81%
1/123 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/84 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.81%
1/124 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/122 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.81%
1/123 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/84 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/124 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/122 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/123 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
1.2%
1/84 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.81%
1/124 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/122 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/123 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/84 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/124 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/122 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/123 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
1.2%
1/84 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
0.00%
0/124 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.82%
1/122 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/123 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/84 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Diffuse idiopathic skeletal hyperostosis
|
0.00%
0/124 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/122 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.81%
1/123 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/84 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/124 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/122 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/123 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
1.2%
1/84 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.81%
1/124 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/122 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/123 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/84 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Spinal stenosis
|
0.00%
0/124 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/122 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/123 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
1.2%
1/84 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.00%
0/124 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.82%
1/122 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/123 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/84 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.81%
1/124 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/122 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/123 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/84 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer recurrent
|
0.00%
0/124 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.82%
1/122 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/123 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/84 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ductal adenocarcinoma of pancreas
|
0.00%
0/124 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/122 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.81%
1/123 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/84 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial adenocarcinoma
|
0.00%
0/124 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/122 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.81%
1/123 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/84 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma
|
1.6%
2/124 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/122 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.4%
3/123 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
1.2%
1/84 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant glioma
|
0.00%
0/124 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.82%
1/122 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/123 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/84 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.81%
1/124 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/122 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/123 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/84 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of the vulva
|
0.00%
0/124 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.82%
1/122 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/123 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/84 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/124 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.82%
1/122 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/123 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/84 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.00%
0/124 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/122 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.81%
1/123 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/84 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Sensory loss
|
0.00%
0/124 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.82%
1/122 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/123 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/84 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.81%
1/124 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/122 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/123 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/84 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Major depression
|
0.81%
1/124 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/122 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/123 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/84 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.81%
1/124 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
1.6%
2/122 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/123 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
1.2%
1/84 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Nephrolithiasis
|
2.4%
3/124 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/122 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/123 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
1.2%
1/84 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Pelvi-ureteric obstruction
|
0.00%
0/124 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/122 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/123 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
1.2%
1/84 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.81%
1/124 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/122 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.81%
1/123 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/84 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/124 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/122 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.81%
1/123 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/84 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Shock
|
0.00%
0/124 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/122 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.81%
1/123 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/84 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
Other adverse events
| Measure |
SEMA + CILO/FIR FDC
n=124 participants at risk
Participants received semaglutide (SEMA) 3.0 mg/mL subcutaneous (SC) injection once weekly and cilofexor and firsocostat (CILO/FIR) 30 mg/20 mg fixed-dose combination (FDC) tablet orally, once daily up to 72 weeks.
|
SEMA + PTM CILO/FIR
n=122 participants at risk
Participants received SEMA 3.0 mg/mL SC injection, once weekly and Placebo-To-Match (PTM) CILO/FIR FDC tablet orally, once daily up to 72 weeks.
|
PTM SEMA + CILO/FIR FDC
n=123 participants at risk
Participants received PTM SEMA SC injection, once weekly and CILO/FIR 30 mg/20 mg FDC tablet orally, once daily up to 72 weeks.
|
PTM SEMA + PTM CILO/FIR
n=84 participants at risk
Participants received PTM SEMA SC injection, once weekly and PTM CILO/FIR FDC tablet orally, once daily up to 72 weeks.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
7.3%
9/124 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
8.2%
10/122 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
3.3%
4/123 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
7.1%
6/84 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
8.9%
11/124 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
8.2%
10/122 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
4.9%
6/123 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
13.1%
11/84 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.6%
7/124 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
9.0%
11/122 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
4.9%
6/123 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
9.5%
8/84 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
24.2%
30/124 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
21.3%
26/122 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
8.9%
11/123 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
8.3%
7/84 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
27.4%
34/124 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.5%
25/122 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
13.0%
16/123 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
17.9%
15/84 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
9.7%
12/124 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
1.6%
2/122 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
3.3%
4/123 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
3.6%
3/84 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
5.6%
7/124 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
10.7%
13/122 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.4%
3/123 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.4%
2/84 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
47.6%
59/124 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
40.2%
49/122 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
23.6%
29/123 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
22.6%
19/84 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
21.8%
27/124 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
17.2%
21/122 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.7%
7/123 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
7.1%
6/84 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
General disorders
Fatigue
|
13.7%
17/124 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
13.9%
17/122 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
7.3%
9/123 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
13.1%
11/84 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Bronchitis
|
1.6%
2/124 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.5%
3/122 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
4.1%
5/123 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
6.0%
5/84 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Covid-19
|
16.9%
21/124 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
12.3%
15/122 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
12.2%
15/123 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
16.7%
14/84 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Influenza
|
0.81%
1/124 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
1.6%
2/122 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.4%
3/123 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
6.0%
5/84 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
5.6%
7/124 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
3.3%
4/122 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
4.9%
6/123 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
4.8%
4/84 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Sinusitis
|
6.5%
8/124 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
6.6%
8/122 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
3.3%
4/123 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
7.1%
6/84 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.6%
7/124 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
3.3%
4/122 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
9.8%
12/123 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
4.8%
4/84 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
10.5%
13/124 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
4.9%
6/122 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
6.5%
8/123 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
3.6%
3/84 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
15.3%
19/124 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
16.4%
20/122 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.7%
7/123 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
6.0%
5/84 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
1.6%
2/124 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/122 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.7%
7/123 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.4%
2/84 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
11.3%
14/124 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
3.3%
4/122 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.4%
3/123 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
6.0%
5/84 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.5%
8/124 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
4.9%
6/122 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
9.8%
12/123 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
13.1%
11/84 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.5%
8/124 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.7%
7/122 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
6.5%
8/123 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
8.3%
7/84 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.6%
2/124 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
3.3%
4/122 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.7%
7/123 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
3.6%
3/84 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Dizziness
|
5.6%
7/124 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
8.2%
10/122 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
7.3%
9/123 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
9.5%
8/84 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Headache
|
5.6%
7/124 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
9.0%
11/122 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
9.8%
12/123 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
3.6%
3/84 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.4%
3/124 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.5%
3/122 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.7%
7/123 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
8.3%
7/84 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/124 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.82%
1/122 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
1.6%
2/123 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
6.0%
5/84 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.5%
8/124 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
10.7%
13/122 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
9.8%
12/123 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
7.1%
6/84 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Hypertension
|
2.4%
3/124 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.82%
1/122 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.4%
3/123 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
7.1%
6/84 • All-cause mortality and Adverse events: Up to 72 weeks plus 35 days
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
Additional Information
Gilead Clinical Study Information Center
Gilead Sciences
Phone: 1-833-445-3230 (GILEAD-0)
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met: * The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or * The study has been completed at all study sites for at least 2 years.
- Publication restrictions are in place
Restriction type: OTHER