Trial Outcomes & Findings for Study of Cilofexor in Adults With Primary Sclerosing Cholangitis (NCT NCT03890120)
NCT ID: NCT03890120
Last Updated: 2023-11-29
Results Overview
Progression of liver fibrosis was defined as having a ≥ 1-stage increase from baseline in fibrosis according to the Ludwig classification at Blinded Phase Week 96. The stages of fibrosis was assessed according to Ludwig classification. Ludwig classification fibrosis stages range from 0 to 4, with higher scores indicating greater fibrosis (0=no fibrosis, 4=cirrhosis).
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
419 participants
Primary outcome timeframe
Blinded Phase Week 96
Results posted on
2023-11-29
Participant Flow
Participants were enrolled at study sites in Europe, North America, Oceania, and Asia.
587 participants were screened.
Participant milestones
| Measure |
Cilofexor 100 mg (Blinded Phase)
Participants received cilofexor 100 mg tablet, orally, once daily for up to 100.3 weeks.
|
Placebo (Blinded Phase)
Participants received placebo to match cilofexor 100 mg tablet, orally, once daily for up to 98.1 weeks.
|
Cilofexor From Cilofexor 100 mg (OLE Phase)
Participants who received cilofexor in blinded phase and had entered the open-label extension (OLE) phase received open-label cilofexor 100 mg tablet, orally, once daily for up to 44.7 weeks.
|
Cilofexor From Placebo (OLE Phase)
Participants who received placebo in blinded phase and had entered the OLE phase received open-label cilofexor 100 mg tablet, orally, once daily for up to 45.0 weeks.
|
|---|---|---|---|---|
|
Blinded Treatment Phase (100.3 Weeks)
STARTED
|
278
|
141
|
0
|
0
|
|
Blinded Treatment Phase (100.3 Weeks)
COMPLETED
|
123
|
66
|
0
|
0
|
|
Blinded Treatment Phase (100.3 Weeks)
NOT COMPLETED
|
155
|
75
|
0
|
0
|
|
Open-Label Extension Phase (45 Weeks)
STARTED
|
0
|
0
|
80
|
45
|
|
Open-Label Extension Phase (45 Weeks)
COMPLETED
|
0
|
0
|
0
|
0
|
|
Open-Label Extension Phase (45 Weeks)
NOT COMPLETED
|
0
|
0
|
80
|
45
|
Reasons for withdrawal
| Measure |
Cilofexor 100 mg (Blinded Phase)
Participants received cilofexor 100 mg tablet, orally, once daily for up to 100.3 weeks.
|
Placebo (Blinded Phase)
Participants received placebo to match cilofexor 100 mg tablet, orally, once daily for up to 98.1 weeks.
|
Cilofexor From Cilofexor 100 mg (OLE Phase)
Participants who received cilofexor in blinded phase and had entered the open-label extension (OLE) phase received open-label cilofexor 100 mg tablet, orally, once daily for up to 44.7 weeks.
|
Cilofexor From Placebo (OLE Phase)
Participants who received placebo in blinded phase and had entered the OLE phase received open-label cilofexor 100 mg tablet, orally, once daily for up to 45.0 weeks.
|
|---|---|---|---|---|
|
Blinded Treatment Phase (100.3 Weeks)
Study terminated by sponsor
|
119
|
57
|
0
|
0
|
|
Blinded Treatment Phase (100.3 Weeks)
Adverse Event
|
17
|
7
|
0
|
0
|
|
Blinded Treatment Phase (100.3 Weeks)
Withdrew consent
|
12
|
4
|
0
|
0
|
|
Blinded Treatment Phase (100.3 Weeks)
Lost to Follow-up
|
4
|
1
|
0
|
0
|
|
Blinded Treatment Phase (100.3 Weeks)
Investigator's discretion
|
1
|
2
|
0
|
0
|
|
Blinded Treatment Phase (100.3 Weeks)
Randomized but never treated
|
1
|
2
|
0
|
0
|
|
Blinded Treatment Phase (100.3 Weeks)
Death
|
1
|
0
|
0
|
0
|
|
Blinded Treatment Phase (100.3 Weeks)
Non-compliance with study drug
|
0
|
1
|
0
|
0
|
|
Blinded Treatment Phase (100.3 Weeks)
Pregnancy
|
0
|
1
|
0
|
0
|
|
Open-Label Extension Phase (45 Weeks)
Study terminated by sponsor
|
0
|
0
|
76
|
42
|
|
Open-Label Extension Phase (45 Weeks)
Adverse Event
|
0
|
0
|
3
|
1
|
|
Open-Label Extension Phase (45 Weeks)
Lost to Follow-up
|
0
|
0
|
0
|
2
|
|
Open-Label Extension Phase (45 Weeks)
Withdrew consent
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Participants in the Safety Analysis Set with available data were analyzed.
Baseline characteristics by cohort
| Measure |
Cilofexor 100 mg (Blinded Phase)
n=277 Participants
Participants received cilofexor 100 mg tablet, orally, once daily for up to 100.3 weeks.
|
Placebo (Blinded Phase)
n=139 Participants
Participants received placebo to match cilofexor 100 mg tablet, orally, once daily for up to 98.1 weeks
|
Total
n=416 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=277 Participants
|
0 Participants
n=139 Participants
|
1 Participants
n=416 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
258 Participants
n=277 Participants
|
133 Participants
n=139 Participants
|
391 Participants
n=416 Participants
|
|
Age, Categorical
>=65 years
|
18 Participants
n=277 Participants
|
6 Participants
n=139 Participants
|
24 Participants
n=416 Participants
|
|
Age, Continuous
|
43 years
STANDARD_DEVIATION 13.1 • n=277 Participants
|
44 years
STANDARD_DEVIATION 12.8 • n=139 Participants
|
44 years
STANDARD_DEVIATION 13.0 • n=416 Participants
|
|
Sex: Female, Male
Female
|
107 Participants
n=277 Participants
|
52 Participants
n=139 Participants
|
159 Participants
n=416 Participants
|
|
Sex: Female, Male
Male
|
170 Participants
n=277 Participants
|
87 Participants
n=139 Participants
|
257 Participants
n=416 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
11 Participants
n=277 Participants
|
3 Participants
n=139 Participants
|
14 Participants
n=416 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
258 Participants
n=277 Participants
|
130 Participants
n=139 Participants
|
388 Participants
n=416 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=277 Participants
|
6 Participants
n=139 Participants
|
14 Participants
n=416 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
228 Participants
n=277 Participants
|
117 Participants
n=139 Participants
|
345 Participants
n=416 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
28 Participants
n=277 Participants
|
10 Participants
n=139 Participants
|
38 Participants
n=416 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
10 Participants
n=277 Participants
|
7 Participants
n=139 Participants
|
17 Participants
n=416 Participants
|
|
Race/Ethnicity, Customized
Race · Unknown or Not Reported
|
6 Participants
n=277 Participants
|
5 Participants
n=139 Participants
|
11 Participants
n=416 Participants
|
|
Race/Ethnicity, Customized
Race · Other or More Than One Race
|
5 Participants
n=277 Participants
|
0 Participants
n=139 Participants
|
5 Participants
n=416 Participants
|
|
Region of Enrollment
United States
|
114 Participants
n=277 Participants
|
57 Participants
n=139 Participants
|
171 Participants
n=416 Participants
|
|
Region of Enrollment
Japan
|
19 Participants
n=277 Participants
|
8 Participants
n=139 Participants
|
27 Participants
n=416 Participants
|
|
Region of Enrollment
United Kingdom
|
11 Participants
n=277 Participants
|
8 Participants
n=139 Participants
|
19 Participants
n=416 Participants
|
|
Region of Enrollment
Switzerland
|
2 Participants
n=277 Participants
|
4 Participants
n=139 Participants
|
6 Participants
n=416 Participants
|
|
Region of Enrollment
Spain
|
13 Participants
n=277 Participants
|
3 Participants
n=139 Participants
|
16 Participants
n=416 Participants
|
|
Region of Enrollment
New Zealand
|
4 Participants
n=277 Participants
|
2 Participants
n=139 Participants
|
6 Participants
n=416 Participants
|
|
Region of Enrollment
Canada
|
28 Participants
n=277 Participants
|
10 Participants
n=139 Participants
|
38 Participants
n=416 Participants
|
|
Region of Enrollment
Austria
|
3 Participants
n=277 Participants
|
1 Participants
n=139 Participants
|
4 Participants
n=416 Participants
|
|
Region of Enrollment
Belgium
|
4 Participants
n=277 Participants
|
2 Participants
n=139 Participants
|
6 Participants
n=416 Participants
|
|
Region of Enrollment
Finland
|
11 Participants
n=277 Participants
|
8 Participants
n=139 Participants
|
19 Participants
n=416 Participants
|
|
Region of Enrollment
Denmark
|
4 Participants
n=277 Participants
|
3 Participants
n=139 Participants
|
7 Participants
n=416 Participants
|
|
Region of Enrollment
Italy
|
17 Participants
n=277 Participants
|
6 Participants
n=139 Participants
|
23 Participants
n=416 Participants
|
|
Region of Enrollment
Israel
|
8 Participants
n=277 Participants
|
3 Participants
n=139 Participants
|
11 Participants
n=416 Participants
|
|
Region of Enrollment
Australia
|
18 Participants
n=277 Participants
|
13 Participants
n=139 Participants
|
31 Participants
n=416 Participants
|
|
Region of Enrollment
France
|
8 Participants
n=277 Participants
|
6 Participants
n=139 Participants
|
14 Participants
n=416 Participants
|
|
Region of Enrollment
Germany
|
13 Participants
n=277 Participants
|
5 Participants
n=139 Participants
|
18 Participants
n=416 Participants
|
|
Alkaline Phosphatase (ALP)
|
223 units per liter (U/L)
STANDARD_DEVIATION 177.7 • n=277 Participants
|
243 units per liter (U/L)
STANDARD_DEVIATION 189.5 • n=139 Participants
|
230 units per liter (U/L)
STANDARD_DEVIATION 181.7 • n=416 Participants
|
|
Aspartate Aminotransferase (AST)
|
49 U/L
STANDARD_DEVIATION 34.1 • n=277 Participants
|
51 U/L
STANDARD_DEVIATION 34.6 • n=139 Participants
|
50 U/L
STANDARD_DEVIATION 34.2 • n=416 Participants
|
|
Fasting Total Bile Acids
|
24.2 micromoles per liter (μmol/L)
STANDARD_DEVIATION 37.57 • n=262 Participants • Participants in the Safety Analysis Set with available data were analyzed.
|
18.6 micromoles per liter (μmol/L)
STANDARD_DEVIATION 22.49 • n=132 Participants • Participants in the Safety Analysis Set with available data were analyzed.
|
22.4 micromoles per liter (μmol/L)
STANDARD_DEVIATION 33.36 • n=394 Participants • Participants in the Safety Analysis Set with available data were analyzed.
|
|
Enhanced Liver Fibrosis (ELF™) Test Score
|
9.14 score on a scale
STANDARD_DEVIATION 0.910 • n=276 Participants • Participants in the Safety Analysis Set with available data were analyzed.
|
9.13 score on a scale
STANDARD_DEVIATION 0.963 • n=137 Participants • Participants in the Safety Analysis Set with available data were analyzed.
|
9.13 score on a scale
STANDARD_DEVIATION 0.927 • n=413 Participants • Participants in the Safety Analysis Set with available data were analyzed.
|
|
Fibroscan Score
|
7.8 kilopascals (kPa)
STANDARD_DEVIATION 4.91 • n=253 Participants • Participants in the safety analysis set with available data were analyzed.
|
8.0 kilopascals (kPa)
STANDARD_DEVIATION 4.07 • n=125 Participants • Participants in the safety analysis set with available data were analyzed.
|
7.8 kilopascals (kPa)
STANDARD_DEVIATION 4.64 • n=378 Participants • Participants in the safety analysis set with available data were analyzed.
|
PRIMARY outcome
Timeframe: Blinded Phase Week 96Population: Full Analysis Set included all randomized participants who took at least 1 dose of study drug. Participants in the Full Analysis Set who had nonmissing data at both baseline and Week 96 in the Blinded Study Phase were analyzed.
Progression of liver fibrosis was defined as having a ≥ 1-stage increase from baseline in fibrosis according to the Ludwig classification at Blinded Phase Week 96. The stages of fibrosis was assessed according to Ludwig classification. Ludwig classification fibrosis stages range from 0 to 4, with higher scores indicating greater fibrosis (0=no fibrosis, 4=cirrhosis).
Outcome measures
| Measure |
Cilofexor 100 mg (Blinded Phase)
n=133 Participants
Participants received cilofexor 100 mg tablet, orally, once daily for up to 100.3 weeks.
|
Placebo (Blinded Phase)
n=64 Participants
Participants received placebo to match cilofexor 100 mg tablet, orally, once daily for up to 98.1 weeks.
|
|---|---|---|
|
Percentage of Participants With Progression of Liver Fibrosis at Blinded Phase Week 96
|
30.8 percentage of participants
|
32.8 percentage of participants
|
SECONDARY outcome
Timeframe: First dose date in the Blinded Phase up to 100.3 weeks plus 30 daysPopulation: Safety Analysis Set included all participants who took at least 1 dose of study drug.
An AE was any untoward medical occurrence in a clinical study participant administered a study drug that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of a study drug, whether or not the AE is considered related to the study drug. For Blinded Study Phase and OLE Phase, TEAEs were defined as 1 or both of the following: Any AEs with an onset date on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug and/or any AEs leading to premature discontinuation of study drug.
Outcome measures
| Measure |
Cilofexor 100 mg (Blinded Phase)
n=277 Participants
Participants received cilofexor 100 mg tablet, orally, once daily for up to 100.3 weeks.
|
Placebo (Blinded Phase)
n=139 Participants
Participants received placebo to match cilofexor 100 mg tablet, orally, once daily for up to 98.1 weeks.
|
|---|---|---|
|
Percentage of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) in The Blinded Phase
|
97.1 percentage of participants
|
95.0 percentage of participants
|
SECONDARY outcome
Timeframe: First dose date in the OLE Phase up to 45 weeks plus 30 daysPopulation: OLE Analysis Set included all participants who took at least 1 dose of study drug in the OLE Phase.
An AE was any untoward medical occurrence in a clinical study participant administered a study drug that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of a study drug, whether or not the AE is considered related to the study drug. For Blinded Study Phase and OLE Phase, TEAEs were defined as 1 or both of the following: Any AEs with an onset date on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug and/or any AEs leading to premature discontinuation of study drug.
Outcome measures
| Measure |
Cilofexor 100 mg (Blinded Phase)
n=80 Participants
Participants received cilofexor 100 mg tablet, orally, once daily for up to 100.3 weeks.
|
Placebo (Blinded Phase)
n=45 Participants
Participants received placebo to match cilofexor 100 mg tablet, orally, once daily for up to 98.1 weeks.
|
|---|---|---|
|
Percentage of Participants Who Experienced TEAEs in The OLE Phase
|
66.3 percentage of participants
|
73.3 percentage of participants
|
SECONDARY outcome
Timeframe: First dose date in the Blinded Phase up to 100.3 weeks plus 30 daysPopulation: Participants in the Safety Analysis Set were analyzed.
An SAE was defined as an event that, at any dose, results in the following: death, a life-threatening situation; in-patient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, a congenital anomaly/birth defect or a medically important event or reaction.
Outcome measures
| Measure |
Cilofexor 100 mg (Blinded Phase)
n=277 Participants
Participants received cilofexor 100 mg tablet, orally, once daily for up to 100.3 weeks.
|
Placebo (Blinded Phase)
n=139 Participants
Participants received placebo to match cilofexor 100 mg tablet, orally, once daily for up to 98.1 weeks.
|
|---|---|---|
|
Percentage of Participants Who Experienced Treatment-emergent Serious Adverse Events (SAEs) in the Blinded Phase
|
19.1 percentage of participants
|
18.7 percentage of participants
|
SECONDARY outcome
Timeframe: First dose date in the OLE Phase up to 45 weeks plus 30 daysPopulation: Participants in the OLE Analysis Set were analyzed.
An SAE was defined as an event that, at any dose, results in the following: death, a life-threatening situation; in-patient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, a congenital anomaly/birth defect or a medically important event or reaction.
Outcome measures
| Measure |
Cilofexor 100 mg (Blinded Phase)
n=80 Participants
Participants received cilofexor 100 mg tablet, orally, once daily for up to 100.3 weeks.
|
Placebo (Blinded Phase)
n=45 Participants
Participants received placebo to match cilofexor 100 mg tablet, orally, once daily for up to 98.1 weeks.
|
|---|---|---|
|
Percentage of Participants Who Experienced Treatment-emergent SAEs in the OLE Phase
|
11.3 percentage of participants
|
2.2 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Blinded Phase Week 96Population: Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
Cilofexor 100 mg (Blinded Phase)
n=146 Participants
Participants received cilofexor 100 mg tablet, orally, once daily for up to 100.3 weeks.
|
Placebo (Blinded Phase)
n=74 Participants
Participants received placebo to match cilofexor 100 mg tablet, orally, once daily for up to 98.1 weeks.
|
|---|---|---|
|
Change From Baseline in Serum Concentrations of Alkaline Phosphatase (ALP) at Blinded Phase Week 96
|
0 units per liter (U/L)
Interval -17.0 to 16.0
|
3 units per liter (U/L)
Interval -19.0 to 25.0
|
SECONDARY outcome
Timeframe: Baseline, Blinded Phase Week 96Population: Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
Cilofexor 100 mg (Blinded Phase)
n=145 Participants
Participants received cilofexor 100 mg tablet, orally, once daily for up to 100.3 weeks.
|
Placebo (Blinded Phase)
n=74 Participants
Participants received placebo to match cilofexor 100 mg tablet, orally, once daily for up to 98.1 weeks.
|
|---|---|---|
|
Change From Baseline in Serum Concentrations of Alanine Aminotransferase (ALT) at Blinded Phase Week 96
|
-13 U/L
Interval -20.0 to -6.0
|
-3 U/L
Interval -12.0 to 6.0
|
SECONDARY outcome
Timeframe: Baseline, Blinded Phase Week 96Population: Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
Cilofexor 100 mg (Blinded Phase)
n=147 Participants
Participants received cilofexor 100 mg tablet, orally, once daily for up to 100.3 weeks.
|
Placebo (Blinded Phase)
n=74 Participants
Participants received placebo to match cilofexor 100 mg tablet, orally, once daily for up to 98.1 weeks.
|
|---|---|---|
|
Change From Baseline in Serum Concentrations of Fasting Total Bile Acids at Blinded Phase Week 96
|
7.2 micromoles per liter (μmol/L)
Interval 0.9 to 13.5
|
9.8 micromoles per liter (μmol/L)
Interval 1.8 to 17.9
|
SECONDARY outcome
Timeframe: Baseline, Blinded Phase Week 96Population: Participants in the Full Analysis Set with available data who had nonmissing data at both baseline and Week 96 in the blinded phase were analyzed.
The stages of fibrosis was assessed according to Ludwig classification. Ludwig classification fibrosis stages range from 0 to 4, with higher scores indicating greater fibrosis (0=no fibrosis, 4=cirrhosis).The percentage of participants with ≥ 25% reduction in serum ALP Concentration from baseline and no increase in fibrosis according to the Ludwig Classification at Blinded Phase Week 96 was analyzed.
Outcome measures
| Measure |
Cilofexor 100 mg (Blinded Phase)
n=122 Participants
Participants received cilofexor 100 mg tablet, orally, once daily for up to 100.3 weeks.
|
Placebo (Blinded Phase)
n=61 Participants
Participants received placebo to match cilofexor 100 mg tablet, orally, once daily for up to 98.1 weeks.
|
|---|---|---|
|
Percentage of Participants With ≥ 25% Relative Reduction in Serum ALP Concentration From Baseline and No Worsening of Fibrosis According to the Ludwig Classification at Blinded Phase Week 96
|
9.8 percentage of participants
|
6.6 percentage of participants
|
SECONDARY outcome
Timeframe: Blinded Phase Week 96Population: Participants in the Full Analysis Set with available data who had nonmissing data at both baseline and Week 96 in the blinded phase were analyzed.
Fibrosis improvement was defined as having ≥ 1-stage decrease from baseline in fibrosis according to the Ludwig classification score at Blinded Study Phase Week 96. The stages of fibrosis was assessed according to Ludwig classification. Ludwig classification fibrosis stages range from 0 to 4, with higher scores indicating greater fibrosis (0=no fibrosis, 4=cirrhosis).
Outcome measures
| Measure |
Cilofexor 100 mg (Blinded Phase)
n=133 Participants
Participants received cilofexor 100 mg tablet, orally, once daily for up to 100.3 weeks.
|
Placebo (Blinded Phase)
n=64 Participants
Participants received placebo to match cilofexor 100 mg tablet, orally, once daily for up to 98.1 weeks.
|
|---|---|---|
|
Percentage of Participants With Fibrosis Improvement According to the Ludwig Classification at Blinded Phase Week 96
|
25.6 percentage of participants
|
17.2 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Blinded Phase Week 96Population: Participants in the Full Analysis Set with available data were analyzed.
The PSC-PRO addressed the severity of common everyday symptoms of PSC (eg, pruritus, fatigue, and right upper quadrant abdominal discomfort); and their functional impact (eg, on physical function, activities of daily living, and work productivity, etc). PSC-PRO module 1 - PSC symptoms contains a total of 12 questions asking about the severity of specific PSC symptoms on a scale of 0 (no symptoms) to 10 (symptoms as bad as you could imagine) with a 24-hour recall period. The total score, which is computed as 12 times the average of nonmissing scores of the 12 questions, can potentially range between 0 and 120, with higher scores indicating more severe symptoms. A positive change from baseline indicates worsening of symptoms.
Outcome measures
| Measure |
Cilofexor 100 mg (Blinded Phase)
n=274 Participants
Participants received cilofexor 100 mg tablet, orally, once daily for up to 100.3 weeks.
|
Placebo (Blinded Phase)
n=137 Participants
Participants received placebo to match cilofexor 100 mg tablet, orally, once daily for up to 98.1 weeks.
|
|---|---|---|
|
Change From Baseline in Primary Sclerosing Cholangitis (PSC) Symptoms - Module 1 Based on Disease-specific Patient Reported Outcome (PSC-PRO) at Blinded Phase Week 96
Baseline
|
11 score on a scale
Standard Deviation 11.0
|
11 score on a scale
Standard Deviation 11.8
|
|
Change From Baseline in Primary Sclerosing Cholangitis (PSC) Symptoms - Module 1 Based on Disease-specific Patient Reported Outcome (PSC-PRO) at Blinded Phase Week 96
Change at Blinded Phase Week 96
|
1 score on a scale
Standard Deviation 9.0
|
0 score on a scale
Standard Deviation 6.8
|
SECONDARY outcome
Timeframe: Baseline, Blinded Phase Week 96Population: Participants in the Full Analysis Set with available data were analyzed.
The Enhanced Liver Fibrosis (ELF™) test is a composite of three serum biomarkers of hepatobiliary fibrosis: hyaluronic acid, procollagen III amino-terminal peptide, and tissue inhibitor of metalloproteinase. A typical range for ELF™ test scores in PSC is between 6 and 14. Higher ELF™ test scores are associated with more severe liver disease. A positive change from baseline indicated worsening of fibrosis.
Outcome measures
| Measure |
Cilofexor 100 mg (Blinded Phase)
n=163 Participants
Participants received cilofexor 100 mg tablet, orally, once daily for up to 100.3 weeks.
|
Placebo (Blinded Phase)
n=78 Participants
Participants received placebo to match cilofexor 100 mg tablet, orally, once daily for up to 98.1 weeks.
|
|---|---|---|
|
Change From Baseline in Enhanced Liver Fibrosis (ELF™ ) Test Score at Blinded Phase Week 96
|
0.27 score on a scale
Interval 0.16 to 0.38
|
0.30 score on a scale
Interval 0.15 to 0.45
|
SECONDARY outcome
Timeframe: Baseline, Blinded Phase Week 96Population: Participants in the Full Analysis Set with available data were analyzed.
Change in liver stiffness was measured by FibroScan® scores. FibroScan measures liver scarring by measuring the stiffness of the liver. It's normally between 2 and 6 kPa. Many people with liver disease(s) have a result that's higher than the normal range. Higher scores indicate increased scarring of the liver. A positive change from baseline indicates severe liver disease(s).
Outcome measures
| Measure |
Cilofexor 100 mg (Blinded Phase)
n=154 Participants
Participants received cilofexor 100 mg tablet, orally, once daily for up to 100.3 weeks.
|
Placebo (Blinded Phase)
n=73 Participants
Participants received placebo to match cilofexor 100 mg tablet, orally, once daily for up to 98.1 weeks.
|
|---|---|---|
|
Change From Baseline in Liver Stiffness by FibroScan® at Blinded Phase Week 96
|
2.4 kilopascals (kPa)
Interval 1.2 to 3.6
|
2.8 kilopascals (kPa)
Interval 1.1 to 4.4
|
Adverse Events
Cilofexor 100 mg (Blinded Phase)
Serious events: 53 serious events
Other events: 232 other events
Deaths: 2 deaths
Placebo (Blinded Phase)
Serious events: 26 serious events
Other events: 109 other events
Deaths: 0 deaths
Cilofexor From Cilofexor 100 mg (OLE Phase)
Serious events: 9 serious events
Other events: 34 other events
Deaths: 0 deaths
Cilofexor From Placebo (OLE Phase)
Serious events: 1 serious events
Other events: 24 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cilofexor 100 mg (Blinded Phase)
n=277 participants at risk
Participants received cilofexor 100 mg tablet, orally, once daily for up to 100.3 weeks.
|
Placebo (Blinded Phase)
n=139 participants at risk
Participants received placebo to match cilofexor 100 mg tablet, orally, once daily for up to 98.1 weeks.
|
Cilofexor From Cilofexor 100 mg (OLE Phase)
n=80 participants at risk
Participants who received cilofexor in blinded phase and had entered the OLE phase received open-label cilofexor 100 mg tablet, orally, once daily for up to 44.7 weeks.
|
Cilofexor From Placebo (OLE Phase)
n=45 participants at risk
Participants who received placebo in blinded phase and had entered the OLE phase received open-label cilofexor 100 mg tablet, orally, once daily for up to 45.0 weeks.
|
|---|---|---|---|---|
|
Infections and infestations
Febrile infection
|
0.36%
1/277 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/139 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/80 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/45 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/277 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.72%
1/139 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/80 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/45 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.1%
3/277 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/139 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
1.2%
1/80 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/45 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.72%
2/277 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/139 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
1.2%
1/80 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/45 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Crohn's disease
|
0.36%
1/277 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/139 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/80 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/45 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea haemorrhagic
|
0.36%
1/277 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/139 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/80 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/45 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Gastritis
|
0.36%
1/277 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/139 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/80 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/45 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Ileus
|
0.36%
1/277 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/139 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/80 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/45 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.00%
0/277 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.72%
1/139 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/80 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/45 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
0.36%
1/277 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/139 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/80 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/45 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Obstructive pancreatitis
|
0.00%
0/277 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/139 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
1.2%
1/80 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/45 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/277 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.72%
1/139 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/80 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/45 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/277 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.72%
1/139 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/80 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/45 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Pouchitis
|
0.36%
1/277 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/139 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/80 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/45 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
General disorders
Chest pain
|
0.00%
0/277 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.72%
1/139 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/80 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/45 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
General disorders
Chills
|
0.36%
1/277 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/139 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/80 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/45 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
General disorders
Pyrexia
|
1.4%
4/277 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.72%
1/139 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/80 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/45 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Bile duct stenosis
|
0.36%
1/277 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
1.4%
2/139 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/80 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/45 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.72%
2/277 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/139 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/80 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/45 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Biliary colic
|
0.36%
1/277 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/139 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/80 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/45 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Biliary dilatation
|
0.36%
1/277 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/139 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/80 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/45 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Cholangitis
|
3.6%
10/277 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
5.0%
7/139 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
2.5%
2/80 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
2.2%
1/45 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Cholangitis acute
|
1.4%
4/277 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/139 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/80 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/45 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Cholangitis sclerosing
|
0.72%
2/277 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/139 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/80 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/45 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
1.4%
4/277 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/139 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/80 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/45 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.72%
2/277 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/139 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/80 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/45 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.00%
0/277 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.72%
1/139 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/80 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/45 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Haemorrhagic cholecystitis
|
0.00%
0/277 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.72%
1/139 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/80 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/45 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Hepatic haematoma
|
0.36%
1/277 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/139 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/80 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/45 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.72%
2/277 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/139 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/80 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/45 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Jaundice
|
0.36%
1/277 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.72%
1/139 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/80 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/45 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.36%
1/277 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.72%
1/139 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/80 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/45 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Immune system disorders
Anaphylactoid reaction
|
0.36%
1/277 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/139 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/80 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/45 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Infections and infestations
Abdominal abscess
|
0.36%
1/277 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/139 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/80 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/45 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/277 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.72%
1/139 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/80 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/45 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Infections and infestations
Cholangitis infective
|
0.00%
0/277 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.72%
1/139 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/80 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/45 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/277 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/139 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
1.2%
1/80 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/45 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Infections and infestations
Gastroenteritis salmonella
|
0.36%
1/277 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/139 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/80 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/45 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Infections and infestations
Infection
|
0.00%
0/277 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.72%
1/139 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/80 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/45 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Infections and infestations
Klebsiella infection
|
0.36%
1/277 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/139 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/80 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/45 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Infections and infestations
Liver abscess
|
0.36%
1/277 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/139 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/80 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/45 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/277 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.72%
1/139 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/80 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/45 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Infections and infestations
Meningitis
|
0.00%
0/277 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.72%
1/139 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/80 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/45 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Infections and infestations
Pharyngitis
|
0.36%
1/277 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/139 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/80 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/45 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Infections and infestations
Pneumonia
|
0.36%
1/277 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/139 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/80 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/45 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Infections and infestations
Post procedural sepsis
|
0.00%
0/277 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.72%
1/139 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/80 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/45 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Infections and infestations
Postoperative abscess
|
0.00%
0/277 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.72%
1/139 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/80 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/45 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Infections and infestations
Sepsis
|
0.36%
1/277 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/139 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/80 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/45 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Infections and infestations
Soft tissue infection
|
0.36%
1/277 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/139 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/80 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/45 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Infections and infestations
Streptococcal sepsis
|
0.36%
1/277 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/139 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/80 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/45 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Infections and infestations
Wound infection
|
0.36%
1/277 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/139 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/80 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/45 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.36%
1/277 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/139 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/80 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/45 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Gastrointestinal procedural complication
|
0.36%
1/277 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/139 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/80 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/45 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.36%
1/277 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.72%
1/139 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/80 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/45 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.00%
0/277 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.72%
1/139 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/80 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/45 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.36%
1/277 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/139 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/80 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/45 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.36%
1/277 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/139 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/80 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/45 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/277 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.72%
1/139 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/80 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/45 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Investigations
Endoscopic retrograde cholangiopancreatography
|
0.36%
1/277 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.72%
1/139 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/80 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/45 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Investigations
General physical condition abnormal
|
0.36%
1/277 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/139 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/80 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/45 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Investigations
Hepatic enzyme abnormal
|
0.36%
1/277 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/139 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/80 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/45 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Investigations
International normalised ratio increased
|
0.36%
1/277 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/139 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/80 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/45 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Type 1 diabetes mellitus
|
0.36%
1/277 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/139 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/80 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/45 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.00%
0/277 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/139 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
1.2%
1/80 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/45 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer metastatic
|
0.36%
1/277 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/139 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/80 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/45 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cholangiocarcinoma
|
0.00%
0/277 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
1.4%
2/139 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/80 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/45 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gallbladder cancer
|
0.36%
1/277 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/139 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/80 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/45 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.00%
0/277 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.72%
1/139 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/80 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/45 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.36%
1/277 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/139 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/80 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/45 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Marginal zone lymphoma
|
0.36%
1/277 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/139 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/80 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/45 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal neoplasm
|
0.36%
1/277 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/139 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/80 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/45 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/277 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.72%
1/139 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/80 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/45 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Nervous system disorders
Dizziness
|
0.36%
1/277 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/139 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/80 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/45 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Nervous system disorders
Headache
|
0.36%
1/277 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/139 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/80 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/45 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Nervous system disorders
Migraine with aura
|
0.36%
1/277 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/139 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/80 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/45 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Nervous system disorders
Peroneal nerve palsy
|
0.36%
1/277 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/139 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/80 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/45 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Nervous system disorders
Syncope
|
0.00%
0/277 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/139 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
1.2%
1/80 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/45 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.36%
1/277 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/139 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/80 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/45 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.36%
1/277 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/139 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
1.2%
1/80 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/45 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.72%
2/277 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/139 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/80 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/45 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Surgical and medical procedures
Cholecystectomy
|
0.36%
1/277 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/139 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/80 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/45 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Surgical and medical procedures
Colorectostomy
|
0.00%
0/277 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/139 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
1.2%
1/80 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/45 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Surgical and medical procedures
Ligament operation
|
0.00%
0/277 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.72%
1/139 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/80 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/45 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Surgical and medical procedures
Liver transplant
|
0.36%
1/277 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/139 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/80 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/45 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Vascular disorders
Hypotension
|
0.00%
0/277 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.72%
1/139 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/80 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/45 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
Other adverse events
| Measure |
Cilofexor 100 mg (Blinded Phase)
n=277 participants at risk
Participants received cilofexor 100 mg tablet, orally, once daily for up to 100.3 weeks.
|
Placebo (Blinded Phase)
n=139 participants at risk
Participants received placebo to match cilofexor 100 mg tablet, orally, once daily for up to 98.1 weeks.
|
Cilofexor From Cilofexor 100 mg (OLE Phase)
n=80 participants at risk
Participants who received cilofexor in blinded phase and had entered the OLE phase received open-label cilofexor 100 mg tablet, orally, once daily for up to 44.7 weeks.
|
Cilofexor From Placebo (OLE Phase)
n=45 participants at risk
Participants who received placebo in blinded phase and had entered the OLE phase received open-label cilofexor 100 mg tablet, orally, once daily for up to 45.0 weeks.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
3.2%
9/277 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
6.5%
9/139 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/80 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
4.4%
2/45 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
13.7%
38/277 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
12.2%
17/139 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
1.2%
1/80 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/45 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
14.4%
40/277 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
14.4%
20/139 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
1.2%
1/80 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
4.4%
2/45 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
7.6%
21/277 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
7.9%
11/139 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
2.5%
2/80 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
2.2%
1/45 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
12.3%
34/277 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
11.5%
16/139 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
5.0%
4/80 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/45 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
4.3%
12/277 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
5.0%
7/139 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
1.2%
1/80 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/45 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
General disorders
Fatigue
|
12.3%
34/277 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
17.3%
24/139 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
3.8%
3/80 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/45 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
General disorders
Pyrexia
|
11.9%
33/277 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
6.5%
9/139 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
3.8%
3/80 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
4.4%
2/45 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Infections and infestations
Covid-19
|
23.5%
65/277 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
18.7%
26/139 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
13.8%
11/80 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
24.4%
11/45 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
5.4%
15/277 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
8.6%
12/139 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/80 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
2.2%
1/45 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.1%
14/277 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
5.0%
7/139 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
1.2%
1/80 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
4.4%
2/45 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
2.9%
8/277 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
3.6%
5/139 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
6.2%
5/80 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/45 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Investigations
Aspartate aminotransferase increased
|
2.9%
8/277 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
5.0%
7/139 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/80 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/45 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.4%
15/277 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
10.1%
14/139 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
2.5%
2/80 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/45 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.6%
21/277 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
5.8%
8/139 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
3.8%
3/80 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/45 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Nervous system disorders
Headache
|
11.6%
32/277 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
12.9%
18/139 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
1.2%
1/80 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/45 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Psychiatric disorders
Insomnia
|
5.1%
14/277 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
1.4%
2/139 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
1.2%
1/80 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
4.4%
2/45 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
48.7%
135/277 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
36.0%
50/139 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
17.5%
14/80 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
24.4%
11/45 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.8%
16/277 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
5.0%
7/139 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
1.2%
1/80 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/45 • All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who took 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