Trial Outcomes & Findings for Study of INT-747 as Monotherapy in Participants With Primary Biliary Cirrhosis (PBC) (NCT NCT00570765)
NCT ID: NCT00570765
Last Updated: 2021-06-22
Results Overview
The percent change in serum ALP from baseline to Day 85 is reported. The baseline value used was the mean of the pretreatment Screening and Day 0 evaluations.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
60 participants
Primary outcome timeframe
Baseline, Day 85
Results posted on
2021-06-22
Participant Flow
Recruitment started Dec. 2007 and completed June 2010. Due to positive Phase 2 data in another study (NCT00550862), power calculations were revised and recruitment ended early. Eligible participants who received treatment in the double-blind (DB) phase could continue receiving obeticholic acid (OCA) in the long-term safety extension (LTSE) phase.
Screening interim allowed for pre-randomization eligibility assessment of 1 to 4 weeks. Other than 3-month (pre-Screening) washout for ursodeoxycholic acid and other medications, no washout or run-in period was defined between Screening and Randomization. During LTSE, OCA dosing (milligrams \[mg\]) remained oral once daily.
Participant milestones
| Measure |
DB OCA 10 mg
OCA 10 mg for 3 months during the DB phase.
|
DB OCA 50 mg
OCA 50 mg for 3 months during the DB phase.
|
DB OCA Placebo
Matching placebo for 3 months during the DB phase.
|
LTSE OCA Total
After completion of the 3-month DB phase, all eligible participants were offered the opportunity to enter an open-label LTSE for up to 96 months beginning at 10 mg OCA. Doses up to 50 mg daily were evaluated.
|
|---|---|---|---|---|
|
DB Phase
STARTED
|
20
|
16
|
24
|
0
|
|
DB Phase
Received at Least 1 Dose of Study Drug
|
20
|
16
|
23
|
0
|
|
DB Phase
Safety Population
|
20
|
16
|
23
|
0
|
|
DB Phase
COMPLETED
|
16
|
9
|
23
|
0
|
|
DB Phase
NOT COMPLETED
|
4
|
7
|
1
|
0
|
|
LTSE Phase
STARTED
|
0
|
0
|
0
|
28
|
|
LTSE Phase
Received at Least 1 Dose of Study Drug
|
0
|
0
|
0
|
28
|
|
LTSE Phase
Safety Population
|
0
|
0
|
0
|
28
|
|
LTSE Phase
COMPLETED
|
0
|
0
|
0
|
16
|
|
LTSE Phase
NOT COMPLETED
|
0
|
0
|
0
|
12
|
Reasons for withdrawal
| Measure |
DB OCA 10 mg
OCA 10 mg for 3 months during the DB phase.
|
DB OCA 50 mg
OCA 50 mg for 3 months during the DB phase.
|
DB OCA Placebo
Matching placebo for 3 months during the DB phase.
|
LTSE OCA Total
After completion of the 3-month DB phase, all eligible participants were offered the opportunity to enter an open-label LTSE for up to 96 months beginning at 10 mg OCA. Doses up to 50 mg daily were evaluated.
|
|---|---|---|---|---|
|
DB Phase
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
|
DB Phase
Protocol Violation
|
0
|
1
|
0
|
0
|
|
DB Phase
Adverse Event
|
3
|
6
|
0
|
0
|
|
DB Phase
Did Not Receive Study Drug
|
0
|
0
|
1
|
0
|
|
LTSE Phase
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
|
LTSE Phase
Adverse Event
|
0
|
0
|
0
|
7
|
|
LTSE Phase
Physician Decision
|
0
|
0
|
0
|
4
|
Baseline Characteristics
Study of INT-747 as Monotherapy in Participants With Primary Biliary Cirrhosis (PBC)
Baseline characteristics by cohort
| Measure |
DB OCA 10 mg
n=20 Participants
OCA 10 mg for 3 months during the DB phase. After completion of the 3-month DB phase, all eligible participants were offered the opportunity to enter an open-label LTSE for up to 96 months beginning at 10 mg OCA. Doses up to 50 mg daily were evaluated.
|
DB OCA 50 mg
n=16 Participants
OCA 50 mg for 3 months during the DB phase. After completion of the 3-month DB phase, all eligible participants were offered the opportunity to enter an open-label LTSE for up to 96 months beginning at 10 mg OCA. Doses up to 50 mg daily were evaluated.
|
DB OCA Placebo
n=23 Participants
Matching placebo for 3 months during the DB phase. After completion of the 3-month DB phase, all eligible participants were offered the opportunity to enter an open-label LTSE for up to 96 months beginning at 10 mg OCA. Doses up to 50 mg daily were evaluated.
|
Total
n=59 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
49 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
10 Participants
n=7 Participants
|
|
Age, Continuous
|
54.8 years
STANDARD_DEVIATION 10.9 • n=99 Participants
|
54.1 years
STANDARD_DEVIATION 7.3 • n=107 Participants
|
55.3 years
STANDARD_DEVIATION 10.0 • n=206 Participants
|
54.8 years
STANDARD_DEVIATION 9.5 • n=7 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
50 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
9 Participants
n=7 Participants
|
|
Region of Enrollment
France
|
2 participants
n=99 Participants
|
1 participants
n=107 Participants
|
1 participants
n=206 Participants
|
4 participants
n=7 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=99 Participants
|
5 participants
n=107 Participants
|
8 participants
n=206 Participants
|
17 participants
n=7 Participants
|
|
Region of Enrollment
Canada
|
3 participants
n=99 Participants
|
2 participants
n=107 Participants
|
4 participants
n=206 Participants
|
9 participants
n=7 Participants
|
|
Region of Enrollment
Spain
|
0 participants
n=99 Participants
|
1 participants
n=107 Participants
|
1 participants
n=206 Participants
|
2 participants
n=7 Participants
|
|
Region of Enrollment
Germany
|
4 participants
n=99 Participants
|
1 participants
n=107 Participants
|
3 participants
n=206 Participants
|
8 participants
n=7 Participants
|
|
Region of Enrollment
United Kingdom
|
7 participants
n=99 Participants
|
6 participants
n=107 Participants
|
6 participants
n=206 Participants
|
19 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Baseline, Day 85Population: Intention-to-treat (ITT): participants randomized to receive investigational product regardless of their actual treatment status.
The percent change in serum ALP from baseline to Day 85 is reported. The baseline value used was the mean of the pretreatment Screening and Day 0 evaluations.
Outcome measures
| Measure |
DB OCA 10 mg
n=20 Participants
OCA 10 mg for 3 months during the DB phase. After completion of the 3-month DB phase, all eligible participants were offered the opportunity to enter an open-label LTSE for up to 96 months beginning at 10 mg OCA. Doses up to 50 mg daily were evaluated.
|
DB OCA 50 mg
n=16 Participants
OCA 50 mg for 3 months during the DB phase. After completion of the 3-month DB phase, all eligible participants were offered the opportunity to enter an open-label LTSE for up to 96 months beginning at 10 mg OCA. Doses up to 50 mg daily were evaluated.
|
DB OCA Placebo
n=23 Participants
Matching placebo for 3 months during the DB phase. After completion of the 3-month DB phase, all eligible participants were offered the opportunity to enter an open-label LTSE for up to 96 months beginning at 10 mg OCA. Doses up to 50 mg daily were evaluated.
|
|---|---|---|---|
|
DB Phase: Mean Percent Change In Serum Alkaline Phosphatase (ALP) From Baseline To Day 85
|
-44.5 Percent change
Standard Deviation 24.4
|
-37.6 Percent change
Standard Deviation 21.0
|
0.4 Percent change
Standard Deviation 15.3
|
SECONDARY outcome
Timeframe: Baseline, Day 85Population: Intention-to-treat (ITT): participants randomized to receive investigational product regardless of their actual treatment status.
As a marker of hepatocellular injury and liver function, the percent change in GGT from baseline to Day 85 is reported.
Outcome measures
| Measure |
DB OCA 10 mg
n=19 Participants
OCA 10 mg for 3 months during the DB phase. After completion of the 3-month DB phase, all eligible participants were offered the opportunity to enter an open-label LTSE for up to 96 months beginning at 10 mg OCA. Doses up to 50 mg daily were evaluated.
|
DB OCA 50 mg
n=15 Participants
OCA 50 mg for 3 months during the DB phase. After completion of the 3-month DB phase, all eligible participants were offered the opportunity to enter an open-label LTSE for up to 96 months beginning at 10 mg OCA. Doses up to 50 mg daily were evaluated.
|
DB OCA Placebo
n=22 Participants
Matching placebo for 3 months during the DB phase. After completion of the 3-month DB phase, all eligible participants were offered the opportunity to enter an open-label LTSE for up to 96 months beginning at 10 mg OCA. Doses up to 50 mg daily were evaluated.
|
|---|---|---|---|
|
DB Phase: Mean Percent Change In Gamma-glutamyl Transferase (GGT) From Baseline To Day 85
|
-73 Percent change
Standard Deviation 18
|
-65 Percent change
Standard Deviation 25
|
-3 Percent change
Standard Deviation 22
|
SECONDARY outcome
Timeframe: Baseline, Day 85Population: Intention-to-treat (ITT): participants randomized to receive investigational product regardless of their actual treatment status.
As a marker of hepatocellular injury and liver function, the percent change in ALT from baseline to Day 85 is reported.
Outcome measures
| Measure |
DB OCA 10 mg
n=19 Participants
OCA 10 mg for 3 months during the DB phase. After completion of the 3-month DB phase, all eligible participants were offered the opportunity to enter an open-label LTSE for up to 96 months beginning at 10 mg OCA. Doses up to 50 mg daily were evaluated.
|
DB OCA 50 mg
n=15 Participants
OCA 50 mg for 3 months during the DB phase. After completion of the 3-month DB phase, all eligible participants were offered the opportunity to enter an open-label LTSE for up to 96 months beginning at 10 mg OCA. Doses up to 50 mg daily were evaluated.
|
DB OCA Placebo
n=22 Participants
Matching placebo for 3 months during the DB phase. After completion of the 3-month DB phase, all eligible participants were offered the opportunity to enter an open-label LTSE for up to 96 months beginning at 10 mg OCA. Doses up to 50 mg daily were evaluated.
|
|---|---|---|---|
|
DB Phase: Mean Percent Change In Alanine Transaminase (ALT) From Baseline To Day 85
|
-37 Percent change
Standard Deviation 35
|
-35 Percent change
Standard Deviation 25
|
-4 Percent change
Standard Deviation 40
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: OCA and its conjugates were quantified by an assay using an extended and improved protocol initially described in peer reviewed literature. The assay was not validated when the study was conducted. A validated assay was established using plasma after the study. But because only serum samples, not plasma samples, were acquired in the study, the levels of OCA and its conjugates were not summarized in the clinical study report, and thus, not used to draw conclusions on exposure.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Day 85Population: Intention-to-treat (ITT): participants randomized to receive investigational product regardless of their actual treatment status.
As a marker of hepatocellular injury and liver function, the percent change in conjugated bilirubin from baseline to Day 85 is reported.
Outcome measures
| Measure |
DB OCA 10 mg
n=18 Participants
OCA 10 mg for 3 months during the DB phase. After completion of the 3-month DB phase, all eligible participants were offered the opportunity to enter an open-label LTSE for up to 96 months beginning at 10 mg OCA. Doses up to 50 mg daily were evaluated.
|
DB OCA 50 mg
n=15 Participants
OCA 50 mg for 3 months during the DB phase. After completion of the 3-month DB phase, all eligible participants were offered the opportunity to enter an open-label LTSE for up to 96 months beginning at 10 mg OCA. Doses up to 50 mg daily were evaluated.
|
DB OCA Placebo
n=22 Participants
Matching placebo for 3 months during the DB phase. After completion of the 3-month DB phase, all eligible participants were offered the opportunity to enter an open-label LTSE for up to 96 months beginning at 10 mg OCA. Doses up to 50 mg daily were evaluated.
|
|---|---|---|---|
|
DB Phase: Mean Percent Change In Conjugated Bilirubin From Baseline To Day 85
|
0.7 Percent Change
Standard Deviation 67.3
|
-1.7 Percent Change
Standard Deviation 39.9
|
30.3 Percent Change
Standard Deviation 69.8
|
SECONDARY outcome
Timeframe: Baseline (DB), Month 24, Month 48, Month 72, Last Available Visit (up to 96 months)Population: Safety Population: participants who received at least 1 dose of open-label investigational product during the LTSE phase.
The percent change in serum ALP from baseline to the last available visit is reported. The DB baseline value was used as the baseline.
Outcome measures
| Measure |
DB OCA 10 mg
n=28 Participants
OCA 10 mg for 3 months during the DB phase. After completion of the 3-month DB phase, all eligible participants were offered the opportunity to enter an open-label LTSE for up to 96 months beginning at 10 mg OCA. Doses up to 50 mg daily were evaluated.
|
DB OCA 50 mg
OCA 50 mg for 3 months during the DB phase. After completion of the 3-month DB phase, all eligible participants were offered the opportunity to enter an open-label LTSE for up to 96 months beginning at 10 mg OCA. Doses up to 50 mg daily were evaluated.
|
DB OCA Placebo
Matching placebo for 3 months during the DB phase. After completion of the 3-month DB phase, all eligible participants were offered the opportunity to enter an open-label LTSE for up to 96 months beginning at 10 mg OCA. Doses up to 50 mg daily were evaluated.
|
|---|---|---|---|
|
LTSE Phase: Median Percent Change In Serum ALP From Baseline To Month 24, Month 48, Month 72, And Last Available Visit
Month 24
|
-43.1 Percent Change
Interval -61.3 to -20.2
|
—
|
—
|
|
LTSE Phase: Median Percent Change In Serum ALP From Baseline To Month 24, Month 48, Month 72, And Last Available Visit
Month 48
|
-44.4 Percent Change
Interval -65.5 to -18.6
|
—
|
—
|
|
LTSE Phase: Median Percent Change In Serum ALP From Baseline To Month 24, Month 48, Month 72, And Last Available Visit
Month 72
|
-33.4 Percent Change
Interval -64.5 to -17.9
|
—
|
—
|
|
LTSE Phase: Median Percent Change In Serum ALP From Baseline To Month 24, Month 48, Month 72, And Last Available Visit
Last Available Visit
|
-31.8 Percent Change
Interval -57.5 to -14.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (DB), Month 24, Month 48, Month 72, Last Available Visit (up to 96 months)Population: Safety Population: participants who received at least 1 dose of open-label investigational product during the LTSE phase.
The percent change in serum ALP from baseline to the last available visit is reported. The DB baseline value was used as the baseline.
Outcome measures
| Measure |
DB OCA 10 mg
n=28 Participants
OCA 10 mg for 3 months during the DB phase. After completion of the 3-month DB phase, all eligible participants were offered the opportunity to enter an open-label LTSE for up to 96 months beginning at 10 mg OCA. Doses up to 50 mg daily were evaluated.
|
DB OCA 50 mg
OCA 50 mg for 3 months during the DB phase. After completion of the 3-month DB phase, all eligible participants were offered the opportunity to enter an open-label LTSE for up to 96 months beginning at 10 mg OCA. Doses up to 50 mg daily were evaluated.
|
DB OCA Placebo
Matching placebo for 3 months during the DB phase. After completion of the 3-month DB phase, all eligible participants were offered the opportunity to enter an open-label LTSE for up to 96 months beginning at 10 mg OCA. Doses up to 50 mg daily were evaluated.
|
|---|---|---|---|
|
LTSE Phase: Mean Percent Change In Serum ALP From Baseline To Month 24, Month 48, Month 72, And Last Available Visit
Month 24
|
-38.8 Percent Change
Standard Deviation 29.7
|
—
|
—
|
|
LTSE Phase: Mean Percent Change In Serum ALP From Baseline To Month 24, Month 48, Month 72, And Last Available Visit
Month 48
|
-39.3 Percent Change
Standard Deviation 36.6
|
—
|
—
|
|
LTSE Phase: Mean Percent Change In Serum ALP From Baseline To Month 24, Month 48, Month 72, And Last Available Visit
Month 72
|
-31.7 Percent Change
Standard Deviation 57.3
|
—
|
—
|
|
LTSE Phase: Mean Percent Change In Serum ALP From Baseline To Month 24, Month 48, Month 72, And Last Available Visit
Last Available Visit
|
-30.4 Percent Change
Standard Deviation 36.6
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (DB), Last Available Visit (up to 96 months)Population: Safety Population: participants who received at least 1 dose of open-label investigational product during the LTSE phase.
As a marker of hepatocellular injury and liver function, the percent change in GGT from baseline to the last available visit is reported. The DB baseline value was used as the baseline.
Outcome measures
| Measure |
DB OCA 10 mg
n=28 Participants
OCA 10 mg for 3 months during the DB phase. After completion of the 3-month DB phase, all eligible participants were offered the opportunity to enter an open-label LTSE for up to 96 months beginning at 10 mg OCA. Doses up to 50 mg daily were evaluated.
|
DB OCA 50 mg
OCA 50 mg for 3 months during the DB phase. After completion of the 3-month DB phase, all eligible participants were offered the opportunity to enter an open-label LTSE for up to 96 months beginning at 10 mg OCA. Doses up to 50 mg daily were evaluated.
|
DB OCA Placebo
Matching placebo for 3 months during the DB phase. After completion of the 3-month DB phase, all eligible participants were offered the opportunity to enter an open-label LTSE for up to 96 months beginning at 10 mg OCA. Doses up to 50 mg daily were evaluated.
|
|---|---|---|---|
|
LTSE: Median Percent Change In GGT From Baseline To Last Available Visit
|
-71.1 Percent Change
Interval -84.3 to -33.8
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (DB), Last Available Visit (up to 96 months)Population: Safety Population: participants who received at least 1 dose of open-label investigational product during the LTSE phase.
As a marker of hepatocellular injury and liver function, the percent change in GGT from baseline to the last available visit is reported. The DB baseline value was used as the baseline.
Outcome measures
| Measure |
DB OCA 10 mg
n=28 Participants
OCA 10 mg for 3 months during the DB phase. After completion of the 3-month DB phase, all eligible participants were offered the opportunity to enter an open-label LTSE for up to 96 months beginning at 10 mg OCA. Doses up to 50 mg daily were evaluated.
|
DB OCA 50 mg
OCA 50 mg for 3 months during the DB phase. After completion of the 3-month DB phase, all eligible participants were offered the opportunity to enter an open-label LTSE for up to 96 months beginning at 10 mg OCA. Doses up to 50 mg daily were evaluated.
|
DB OCA Placebo
Matching placebo for 3 months during the DB phase. After completion of the 3-month DB phase, all eligible participants were offered the opportunity to enter an open-label LTSE for up to 96 months beginning at 10 mg OCA. Doses up to 50 mg daily were evaluated.
|
|---|---|---|---|
|
LTSE: Mean Percent Change In GGT From Baseline To Last Available Visit
|
-55.6 Percent Change
Standard Deviation 41.4
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (DB), Last Available Visit (up to 96 months)Population: Safety Population: participants who received at least 1 dose of open-label investigational product during the LTSE phase.
As a marker of hepatocellular injury and liver function, the percent change in ALT from baseline to the last available visit is reported. The DB baseline value was used as the baseline.
Outcome measures
| Measure |
DB OCA 10 mg
n=28 Participants
OCA 10 mg for 3 months during the DB phase. After completion of the 3-month DB phase, all eligible participants were offered the opportunity to enter an open-label LTSE for up to 96 months beginning at 10 mg OCA. Doses up to 50 mg daily were evaluated.
|
DB OCA 50 mg
OCA 50 mg for 3 months during the DB phase. After completion of the 3-month DB phase, all eligible participants were offered the opportunity to enter an open-label LTSE for up to 96 months beginning at 10 mg OCA. Doses up to 50 mg daily were evaluated.
|
DB OCA Placebo
Matching placebo for 3 months during the DB phase. After completion of the 3-month DB phase, all eligible participants were offered the opportunity to enter an open-label LTSE for up to 96 months beginning at 10 mg OCA. Doses up to 50 mg daily were evaluated.
|
|---|---|---|---|
|
LTSE: Median Percent Change In ALT From Baseline To Last Available Visit
|
-52.2 Percent Change
Interval -68.4 to -11.6
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (DB), Last Available Visit (up to 96 months)Population: Safety Population: participants who received at least 1 dose of open-label investigational product during the LTSE phase.
As a marker of hepatocellular injury and liver function, the percent change in ALT from baseline to the last available visit is reported. The DB baseline value was used as the baseline.
Outcome measures
| Measure |
DB OCA 10 mg
n=28 Participants
OCA 10 mg for 3 months during the DB phase. After completion of the 3-month DB phase, all eligible participants were offered the opportunity to enter an open-label LTSE for up to 96 months beginning at 10 mg OCA. Doses up to 50 mg daily were evaluated.
|
DB OCA 50 mg
OCA 50 mg for 3 months during the DB phase. After completion of the 3-month DB phase, all eligible participants were offered the opportunity to enter an open-label LTSE for up to 96 months beginning at 10 mg OCA. Doses up to 50 mg daily were evaluated.
|
DB OCA Placebo
Matching placebo for 3 months during the DB phase. After completion of the 3-month DB phase, all eligible participants were offered the opportunity to enter an open-label LTSE for up to 96 months beginning at 10 mg OCA. Doses up to 50 mg daily were evaluated.
|
|---|---|---|---|
|
LTSE: Mean Percent Change In ALT From Baseline To Last Available Visit
|
-39.6 Percent Change
Standard Deviation 42.8
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (DB), Last Available Visit (up to 96 months)Population: Safety Population: participants who received at least 1 dose of open-label investigational product during the LTSE phase.
As a marker of hepatocellular injury and liver function, the percent change in conjugated bilirubin from baseline to the last available visit is reported. The DB baseline value was used as the baseline.
Outcome measures
| Measure |
DB OCA 10 mg
n=28 Participants
OCA 10 mg for 3 months during the DB phase. After completion of the 3-month DB phase, all eligible participants were offered the opportunity to enter an open-label LTSE for up to 96 months beginning at 10 mg OCA. Doses up to 50 mg daily were evaluated.
|
DB OCA 50 mg
OCA 50 mg for 3 months during the DB phase. After completion of the 3-month DB phase, all eligible participants were offered the opportunity to enter an open-label LTSE for up to 96 months beginning at 10 mg OCA. Doses up to 50 mg daily were evaluated.
|
DB OCA Placebo
Matching placebo for 3 months during the DB phase. After completion of the 3-month DB phase, all eligible participants were offered the opportunity to enter an open-label LTSE for up to 96 months beginning at 10 mg OCA. Doses up to 50 mg daily were evaluated.
|
|---|---|---|---|
|
LTSE: Median Percent Change In Conjugated Bilirubin From Baseline To Last Available Visit
|
33.3 Percent Change
Interval -11.1 to 100.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (DB), Last Available Visit (up to 96 months)Population: Safety Population: participants who received at least 1 dose of open-label investigational product during the LTSE phase.
As a marker of hepatocellular injury and liver function, the percent change in conjugated bilirubin from baseline to the last available visit is reported. The DB baseline value was used as the baseline.
Outcome measures
| Measure |
DB OCA 10 mg
n=28 Participants
OCA 10 mg for 3 months during the DB phase. After completion of the 3-month DB phase, all eligible participants were offered the opportunity to enter an open-label LTSE for up to 96 months beginning at 10 mg OCA. Doses up to 50 mg daily were evaluated.
|
DB OCA 50 mg
OCA 50 mg for 3 months during the DB phase. After completion of the 3-month DB phase, all eligible participants were offered the opportunity to enter an open-label LTSE for up to 96 months beginning at 10 mg OCA. Doses up to 50 mg daily were evaluated.
|
DB OCA Placebo
Matching placebo for 3 months during the DB phase. After completion of the 3-month DB phase, all eligible participants were offered the opportunity to enter an open-label LTSE for up to 96 months beginning at 10 mg OCA. Doses up to 50 mg daily were evaluated.
|
|---|---|---|---|
|
LTSE: Mean Percent Change In Conjugated Bilirubin From Baseline To Last Available Visit
|
57.8 Percent Change
Standard Deviation 103.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (DB), Last Available Visit (up to 96 months)Population: Safety Population: participants who received at least 1 dose of open-label investigational product during the LTSE phase.
As a marker of hepatocellular injury and liver function, the percent change in total bilirubin from baseline to the last available visit is reported. The DB baseline value was used as the baseline.
Outcome measures
| Measure |
DB OCA 10 mg
n=28 Participants
OCA 10 mg for 3 months during the DB phase. After completion of the 3-month DB phase, all eligible participants were offered the opportunity to enter an open-label LTSE for up to 96 months beginning at 10 mg OCA. Doses up to 50 mg daily were evaluated.
|
DB OCA 50 mg
OCA 50 mg for 3 months during the DB phase. After completion of the 3-month DB phase, all eligible participants were offered the opportunity to enter an open-label LTSE for up to 96 months beginning at 10 mg OCA. Doses up to 50 mg daily were evaluated.
|
DB OCA Placebo
Matching placebo for 3 months during the DB phase. After completion of the 3-month DB phase, all eligible participants were offered the opportunity to enter an open-label LTSE for up to 96 months beginning at 10 mg OCA. Doses up to 50 mg daily were evaluated.
|
|---|---|---|---|
|
LTSE: Median Percent Change In Total Bilirubin From Baseline To Last Available Visit
|
5.2 Percent Change
Interval -21.4 to 25.2
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (DB), Last Available Visit (up to 96 months)Population: Safety Population: participants who received at least 1 dose of open-label investigational product during the LTSE phase.
As a marker of hepatocellular injury and liver function, the percent change in total bilirubin from baseline to the last available visit is reported. The DB baseline value was used as the baseline.
Outcome measures
| Measure |
DB OCA 10 mg
n=28 Participants
OCA 10 mg for 3 months during the DB phase. After completion of the 3-month DB phase, all eligible participants were offered the opportunity to enter an open-label LTSE for up to 96 months beginning at 10 mg OCA. Doses up to 50 mg daily were evaluated.
|
DB OCA 50 mg
OCA 50 mg for 3 months during the DB phase. After completion of the 3-month DB phase, all eligible participants were offered the opportunity to enter an open-label LTSE for up to 96 months beginning at 10 mg OCA. Doses up to 50 mg daily were evaluated.
|
DB OCA Placebo
Matching placebo for 3 months during the DB phase. After completion of the 3-month DB phase, all eligible participants were offered the opportunity to enter an open-label LTSE for up to 96 months beginning at 10 mg OCA. Doses up to 50 mg daily were evaluated.
|
|---|---|---|---|
|
LTSE: Mean Percent Change In Total Bilirubin From Baseline To Last Available Visit
|
2.2 Percent Change
Standard Deviation 35.1
|
—
|
—
|
Adverse Events
DB OCA 10 mg
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
DB OCA 50 mg
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
DB OCA Placebo
Serious events: 1 serious events
Other events: 19 other events
Deaths: 0 deaths
LTSE OCA Total
Serious events: 9 serious events
Other events: 28 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
DB OCA 10 mg
n=20 participants at risk
OCA 10 mg for 3 months during the DB phase.
|
DB OCA 50 mg
n=16 participants at risk
OCA 50 mg for 3 months during the DB phase.
|
DB OCA Placebo
n=23 participants at risk
Matching placebo for 3 months during the DB phase.
|
LTSE OCA Total
n=28 participants at risk
After completion of the 3-month DB phase, all eligible participants were offered the opportunity to enter an open-label LTSE for up to 96 months beginning at 10 mg OCA. Doses up to 50 mg daily were evaluated.
|
|---|---|---|---|---|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/20 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/16 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/23 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
3.6%
1/28 • Number of events 1 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/20 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/16 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/23 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
3.6%
1/28 • Number of events 1 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Cardiac disorders
Tricuspid valve incompetence
|
0.00%
0/20 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/16 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/23 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
3.6%
1/28 • Number of events 1 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/20 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/16 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
4.3%
1/23 • Number of events 1 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/28 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/20 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/16 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/23 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
7.1%
2/28 • Number of events 2 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Vascular disorders
Peripheral ischaemia
|
0.00%
0/20 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/16 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/23 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
3.6%
1/28 • Number of events 1 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
0.00%
0/20 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/16 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/23 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
3.6%
1/28 • Number of events 1 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Reproductive system and breast disorders
Uterine prolapse
|
0.00%
0/14 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/16 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/20 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
4.3%
1/23 • Number of events 1 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Reproductive system and breast disorders
Cystocele
|
0.00%
0/14 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/16 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/20 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
4.3%
1/23 • Number of events 1 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.00%
0/20 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/16 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/23 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
3.6%
1/28 • Number of events 1 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/20 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/16 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/23 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
3.6%
1/28 • Number of events 1 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/20 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/16 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/23 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
3.6%
1/28 • Number of events 1 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
0.00%
0/20 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/16 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/23 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
3.6%
1/28 • Number of events 4 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/20 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/16 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/23 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
3.6%
1/28 • Number of events 1 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/20 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/16 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/23 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
3.6%
1/28 • Number of events 1 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/20 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/16 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/23 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
3.6%
1/28 • Number of events 1 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/20 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/16 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/23 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
3.6%
1/28 • Number of events 1 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/20 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/16 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/23 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
3.6%
1/28 • Number of events 1 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Gastrointestinal disorders
Gastric varices haemorrhage
|
0.00%
0/20 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/16 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/23 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
3.6%
1/28 • Number of events 1 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/20 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/16 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/23 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
3.6%
1/28 • Number of events 1 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/20 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/16 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/23 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
3.6%
1/28 • Number of events 1 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Musculoskeletal and connective tissue disorders
Haemarthrosis
|
0.00%
0/20 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/16 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/23 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
3.6%
1/28 • Number of events 1 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Musculoskeletal and connective tissue disorders
Polyarthritis
|
0.00%
0/20 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/16 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/23 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
3.6%
1/28 • Number of events 1 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/20 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/16 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/23 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
3.6%
1/28 • Number of events 1 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
Other adverse events
| Measure |
DB OCA 10 mg
n=20 participants at risk
OCA 10 mg for 3 months during the DB phase.
|
DB OCA 50 mg
n=16 participants at risk
OCA 50 mg for 3 months during the DB phase.
|
DB OCA Placebo
n=23 participants at risk
Matching placebo for 3 months during the DB phase.
|
LTSE OCA Total
n=28 participants at risk
After completion of the 3-month DB phase, all eligible participants were offered the opportunity to enter an open-label LTSE for up to 96 months beginning at 10 mg OCA. Doses up to 50 mg daily were evaluated.
|
|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.0%
1/20 • Number of events 1 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
6.2%
1/16 • Number of events 1 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
4.3%
1/23 • Number of events 1 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
17.9%
5/28 • Number of events 5 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/20 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
12.5%
2/16 • Number of events 2 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
4.3%
1/23 • Number of events 1 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
28.6%
8/28 • Number of events 12 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/20 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/16 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
17.4%
4/23 • Number of events 5 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
17.9%
5/28 • Number of events 5 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
General disorders
Fatigue
|
0.00%
0/20 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
6.2%
1/16 • Number of events 1 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
13.0%
3/23 • Number of events 3 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
50.0%
14/28 • Number of events 16 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Nervous system disorders
Headache
|
20.0%
4/20 • Number of events 5 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
12.5%
2/16 • Number of events 3 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
21.7%
5/23 • Number of events 6 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
28.6%
8/28 • Number of events 12 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
General disorders
Influenza like illness
|
0.00%
0/20 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
6.2%
1/16 • Number of events 1 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
8.7%
2/23 • Number of events 2 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
10.7%
3/28 • Number of events 7 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Psychiatric disorders
Insomnia
|
5.0%
1/20 • Number of events 2 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
12.5%
2/16 • Number of events 2 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
4.3%
1/23 • Number of events 1 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
17.9%
5/28 • Number of events 6 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Infections and infestations
Nasopharyngitis
|
15.0%
3/20 • Number of events 3 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
6.2%
1/16 • Number of events 1 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
8.7%
2/23 • Number of events 2 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
10.7%
3/28 • Number of events 5 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/20 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
25.0%
4/16 • Number of events 4 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
17.4%
4/23 • Number of events 5 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
39.3%
11/28 • Number of events 19 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Infections and infestations
Urinary tract infection
|
15.0%
3/20 • Number of events 3 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
6.2%
1/16 • Number of events 1 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/23 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
17.9%
5/28 • Number of events 9 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Gastrointestinal disorders
Vomiting
|
5.0%
1/20 • Number of events 1 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
6.2%
1/16 • Number of events 1 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
4.3%
1/23 • Number of events 1 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
14.3%
4/28 • Number of events 8 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/20 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/16 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/23 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
10.7%
3/28 • Number of events 4 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.00%
0/20 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/16 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/23 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
7.1%
2/28 • Number of events 2 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/20 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/16 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/23 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
7.1%
2/28 • Number of events 2 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
5.0%
1/20 • Number of events 1 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/16 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/23 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/28 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Blood and lymphatic system disorders
Lymphoid tissue hyperplasia
|
5.0%
1/20 • Number of events 1 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/16 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/23 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/28 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/20 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/16 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/23 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
10.7%
3/28 • Number of events 4 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/20 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/16 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/23 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
10.7%
3/28 • Number of events 3 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/20 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/16 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/23 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
7.1%
2/28 • Number of events 2 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Eye disorders
Dry eye
|
0.00%
0/20 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
6.2%
1/16 • Number of events 1 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
4.3%
1/23 • Number of events 1 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
10.7%
3/28 • Number of events 3 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Eye disorders
Cataract
|
0.00%
0/20 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/16 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/23 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
7.1%
2/28 • Number of events 2 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Eye disorders
Iritis
|
5.0%
1/20 • Number of events 1 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/16 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/23 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
3.6%
1/28 • Number of events 1 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/20 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
12.5%
2/16 • Number of events 2 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/23 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
32.1%
9/28 • Number of events 11 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/20 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/16 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
8.7%
2/23 • Number of events 2 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
25.0%
7/28 • Number of events 10 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/20 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
12.5%
2/16 • Number of events 2 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/23 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
21.4%
6/28 • Number of events 8 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/20 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
6.2%
1/16 • Number of events 1 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/23 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
17.9%
5/28 • Number of events 7 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/20 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/16 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/23 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
14.3%
4/28 • Number of events 5 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Gastrointestinal disorders
Dry mouth
|
5.0%
1/20 • Number of events 1 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/16 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
4.3%
1/23 • Number of events 1 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
14.3%
4/28 • Number of events 5 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/20 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/16 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
4.3%
1/23 • Number of events 1 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
14.3%
4/28 • Number of events 5 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/20 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
12.5%
2/16 • Number of events 2 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/23 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
17.9%
5/28 • Number of events 5 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/20 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/16 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/23 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
10.7%
3/28 • Number of events 4 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Gastrointestinal disorders
Diverticulum
|
0.00%
0/20 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/16 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/23 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
14.3%
4/28 • Number of events 4 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Gastrointestinal disorders
Abdominal tenderness
|
0.00%
0/20 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/16 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/23 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
10.7%
3/28 • Number of events 3 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Gastrointestinal disorders
Colonic polyp
|
0.00%
0/20 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/16 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/23 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
10.7%
3/28 • Number of events 3 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/20 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/16 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/23 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
10.7%
3/28 • Number of events 3 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/20 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
6.2%
1/16 • Number of events 1 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
4.3%
1/23 • Number of events 1 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
3.6%
1/28 • Number of events 3 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Gastrointestinal disorders
Coeliac disease
|
0.00%
0/20 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/16 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/23 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
7.1%
2/28 • Number of events 2 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/20 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/16 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/23 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
7.1%
2/28 • Number of events 2 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/20 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/16 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/23 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
7.1%
2/28 • Number of events 2 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Gastrointestinal disorders
Faecal incontinence
|
0.00%
0/20 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
6.2%
1/16 • Number of events 1 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/23 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
3.6%
1/28 • Number of events 1 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Gastrointestinal disorders
Faeces pale
|
0.00%
0/20 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
12.5%
2/16 • Number of events 2 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/23 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/28 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Gastrointestinal disorders
Flatulence
|
5.0%
1/20 • Number of events 1 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/16 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/23 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/28 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Gastrointestinal disorders
Glossodynia
|
5.0%
1/20 • Number of events 1 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/16 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/23 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/28 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Gastrointestinal disorders
Parotid gland enlargement
|
0.00%
0/20 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
6.2%
1/16 • Number of events 1 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/23 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/28 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Gastrointestinal disorders
Salivary gland enlargement
|
0.00%
0/20 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
6.2%
1/16 • Number of events 1 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/23 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/28 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
General disorders
Oedema peripheral
|
0.00%
0/20 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/16 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/23 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
25.0%
7/28 • Number of events 11 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
General disorders
Pyrexia
|
0.00%
0/20 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/16 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
8.7%
2/23 • Number of events 2 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
10.7%
3/28 • Number of events 3 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
General disorders
Chest discomfort
|
0.00%
0/20 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/16 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/23 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
7.1%
2/28 • Number of events 2 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
General disorders
Chills
|
5.0%
1/20 • Number of events 1 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/16 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
4.3%
1/23 • Number of events 1 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
7.1%
2/28 • Number of events 2 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
General disorders
Asthenia
|
0.00%
0/20 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
6.2%
1/16 • Number of events 1 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/23 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
3.6%
1/28 • Number of events 1 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
General disorders
Feeling cold
|
0.00%
0/20 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
6.2%
1/16 • Number of events 1 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/23 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/28 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/20 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/16 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/23 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
10.7%
3/28 • Number of events 3 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Hepatobiliary disorders
Hepatic pain
|
5.0%
1/20 • Number of events 1 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/16 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/23 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
3.6%
1/28 • Number of events 1 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/20 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/16 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
4.3%
1/23 • Number of events 1 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
7.1%
2/28 • Number of events 3 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/20 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/16 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/23 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
7.1%
2/28 • Number of events 2 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Immune system disorders
Sarcoidosis
|
5.0%
1/20 • Number of events 1 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/16 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/23 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/28 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/20 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
6.2%
1/16 • Number of events 1 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/23 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
21.4%
6/28 • Number of events 11 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Infections and infestations
Upper respiratory tract infection
|
10.0%
2/20 • Number of events 3 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/16 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/23 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
32.1%
9/28 • Number of events 11 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Infections and infestations
Cystitis
|
0.00%
0/20 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
6.2%
1/16 • Number of events 1 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/23 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
14.3%
4/28 • Number of events 6 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/20 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/16 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/23 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
7.1%
2/28 • Number of events 4 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Infections and infestations
Influenza
|
0.00%
0/20 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/16 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/23 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
7.1%
2/28 • Number of events 4 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Infections and infestations
Ear infection
|
0.00%
0/20 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/16 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/23 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
7.1%
2/28 • Number of events 3 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/20 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/16 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/23 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
10.7%
3/28 • Number of events 3 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Infections and infestations
Eye infection
|
0.00%
0/20 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
6.2%
1/16 • Number of events 1 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/23 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
3.6%
1/28 • Number of events 2 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/20 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/16 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/23 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
7.1%
2/28 • Number of events 2 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/20 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/16 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/23 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
7.1%
2/28 • Number of events 2 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Infections and infestations
Laryngitis
|
0.00%
0/20 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/16 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/23 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
7.1%
2/28 • Number of events 2 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/20 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
6.2%
1/16 • Number of events 1 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/23 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
7.1%
2/28 • Number of events 2 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Infections and infestations
Otitis media
|
0.00%
0/20 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/16 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/23 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
7.1%
2/28 • Number of events 2 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/20 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/16 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/23 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
7.1%
2/28 • Number of events 2 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/20 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/16 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/23 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
7.1%
2/28 • Number of events 2 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Infections and infestations
Tinea pedis
|
0.00%
0/20 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/16 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/23 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
7.1%
2/28 • Number of events 2 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/20 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/16 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/23 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
17.9%
5/28 • Number of events 7 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Injury, poisoning and procedural complications
Contusion
|
5.0%
1/20 • Number of events 1 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/16 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/23 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
14.3%
4/28 • Number of events 6 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/20 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/16 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/23 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
14.3%
4/28 • Number of events 4 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.00%
0/20 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/16 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/23 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
7.1%
2/28 • Number of events 2 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Injury, poisoning and procedural complications
Post-traumatic pain
|
0.00%
0/20 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/16 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/23 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
7.1%
2/28 • Number of events 2 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Investigations
Weight decreased
|
0.00%
0/20 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
6.2%
1/16 • Number of events 1 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/23 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
10.7%
3/28 • Number of events 3 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/20 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/16 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/23 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
7.1%
2/28 • Number of events 2 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Investigations
Cardiac murmur
|
0.00%
0/20 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/16 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/23 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
7.1%
2/28 • Number of events 2 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Investigations
White blood cells urine
|
0.00%
0/20 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
6.2%
1/16 • Number of events 1 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/23 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/28 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/20 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/16 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/23 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
21.4%
6/28 • Number of events 6 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/20 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/16 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
4.3%
1/23 • Number of events 1 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
7.1%
2/28 • Number of events 3 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/20 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/16 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/23 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
7.1%
2/28 • Number of events 2 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.00%
0/20 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/16 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/23 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
7.1%
2/28 • Number of events 2 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/20 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
6.2%
1/16 • Number of events 1 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/23 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/28 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/20 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/16 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
8.7%
2/23 • Number of events 2 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
46.4%
13/28 • Number of events 33 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/20 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/16 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/23 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
21.4%
6/28 • Number of events 12 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/20 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
6.2%
1/16 • Number of events 1 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/23 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
21.4%
6/28 • Number of events 8 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasm
|
5.0%
1/20 • Number of events 1 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/16 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
4.3%
1/23 • Number of events 1 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
17.9%
5/28 • Number of events 7 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/20 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/16 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
4.3%
1/23 • Number of events 1 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
17.9%
5/28 • Number of events 6 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/20 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/16 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/23 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
14.3%
4/28 • Number of events 4 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/20 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/16 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/23 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
7.1%
2/28 • Number of events 3 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Musculoskeletal and connective tissue disorders
Fibromyalgia
|
0.00%
0/20 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/16 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/23 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
7.1%
2/28 • Number of events 2 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/20 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/16 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/23 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
7.1%
2/28 • Number of events 2 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.00%
0/20 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/16 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/23 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
7.1%
2/28 • Number of events 2 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/20 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/16 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/23 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
7.1%
2/28 • Number of events 2 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma
|
0.00%
0/20 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/16 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/23 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
7.1%
2/28 • Number of events 2 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.00%
0/20 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/16 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/23 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
7.1%
2/28 • Number of events 2 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid neoplasm
|
0.00%
0/20 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/16 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/23 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
7.1%
2/28 • Number of events 2 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
0.00%
0/20 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
6.2%
1/16 • Number of events 1 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/23 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/28 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Nervous system disorders
Migraine
|
0.00%
0/20 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
6.2%
1/16 • Number of events 1 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/23 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
10.7%
3/28 • Number of events 6 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/20 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/16 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/23 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
10.7%
3/28 • Number of events 3 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Nervous system disorders
Aphonia
|
0.00%
0/20 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/16 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/23 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
7.1%
2/28 • Number of events 2 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/20 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/16 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/23 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
7.1%
2/28 • Number of events 2 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Nervous system disorders
Facial neuralgia
|
0.00%
0/20 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
6.2%
1/16 • Number of events 1 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/23 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/28 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Nervous system disorders
Irregular sleep phase
|
5.0%
1/20 • Number of events 1 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/16 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/23 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/28 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/20 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/16 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/23 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
10.7%
3/28 • Number of events 3 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/20 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/16 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/23 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
7.1%
2/28 • Number of events 3 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/20 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/16 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/23 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
7.1%
2/28 • Number of events 3 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Renal and urinary disorders
Renal cyst
|
0.00%
0/20 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/16 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/23 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
7.1%
2/28 • Number of events 2 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Reproductive system and breast disorders
Breast mass
|
0.00%
0/20 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/16 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/23 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
7.1%
2/28 • Number of events 2 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Reproductive system and breast disorders
Menorrhagia
|
7.1%
1/14 • Number of events 1 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/16 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/20 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
4.3%
1/23 • Number of events 2 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/14 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/16 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/20 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
8.7%
2/23 • Number of events 2 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Reproductive system and breast disorders
Breast tenderness
|
5.0%
1/20 • Number of events 1 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/16 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/23 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/28 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Reproductive system and breast disorders
Gynaecomastia
|
7.1%
1/14 • Number of events 1 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/16 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/20 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/23 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/20 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/16 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/23 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
7.1%
2/28 • Number of events 5 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/20 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/16 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/23 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
14.3%
4/28 • Number of events 4 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.0%
1/20 • Number of events 1 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/16 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
4.3%
1/23 • Number of events 1 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
7.1%
2/28 • Number of events 4 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
5.0%
1/20 • Number of events 1 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/16 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
4.3%
1/23 • Number of events 1 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
10.7%
3/28 • Number of events 4 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/20 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/16 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/23 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
10.7%
3/28 • Number of events 3 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/20 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/16 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/23 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
7.1%
2/28 • Number of events 2 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/20 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/16 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/23 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
7.1%
2/28 • Number of events 2 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/20 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/16 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/23 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
14.3%
4/28 • Number of events 4 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/20 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
6.2%
1/16 • Number of events 1 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
4.3%
1/23 • Number of events 1 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
10.7%
3/28 • Number of events 3 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Skin and subcutaneous tissue disorders
Spider naevus
|
0.00%
0/20 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/16 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/23 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
10.7%
3/28 • Number of events 3 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
5.0%
1/20 • Number of events 1 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/16 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/23 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
7.1%
2/28 • Number of events 2 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/20 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/16 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/23 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
7.1%
2/28 • Number of events 2 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Skin and subcutaneous tissue disorders
Lichen planus
|
0.00%
0/20 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/16 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/23 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
7.1%
2/28 • Number of events 2 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
5.0%
1/20 • Number of events 1 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/16 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/23 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
7.1%
2/28 • Number of events 2 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/20 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
6.2%
1/16 • Number of events 1 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
4.3%
1/23 • Number of events 2 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
3.6%
1/28 • Number of events 1 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
5.0%
1/20 • Number of events 2 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/16 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/23 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
3.6%
1/28 • Number of events 1 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
5.0%
1/20 • Number of events 2 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/16 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/23 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
3.6%
1/28 • Number of events 1 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Skin and subcutaneous tissue disorders
Vitiligo
|
5.0%
1/20 • Number of events 1 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/16 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/23 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
3.6%
1/28 • Number of events 1 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Skin and subcutaneous tissue disorders
Acne
|
5.0%
1/20 • Number of events 1 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/16 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/23 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/28 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
5.0%
1/20 • Number of events 1 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/16 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/23 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/28 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Vascular disorders
Varicose vein
|
0.00%
0/20 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/16 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/23 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
10.7%
3/28 • Number of events 3 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Vascular disorders
Hypertension
|
0.00%
0/20 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/16 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/23 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
7.1%
2/28 • Number of events 2 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Vascular disorders
Hypotension
|
0.00%
0/20 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/16 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/23 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
7.1%
2/28 • Number of events 2 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Vascular disorders
Hot flush
|
5.0%
1/20 • Number of events 1 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/16 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/23 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
3.6%
1/28 • Number of events 1 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
70.0%
14/20 • Number of events 24 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
93.8%
15/16 • Number of events 22 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
30.4%
7/23 • Number of events 11 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
89.3%
25/28 • Number of events 107 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Gastrointestinal disorders
Abdominal pain
|
5.0%
1/20 • Number of events 1 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
12.5%
2/16 • Number of events 2 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
4.3%
1/23 • Number of events 1 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
21.4%
6/28 • Number of events 10 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/20 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
0.00%
0/16 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
17.4%
4/23 • Number of events 4 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
25.0%
7/28 • Number of events 8 • DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Per protocol, Intercept retains ownership of the study data. Proposed publications based on the study shall be approved prior to submission for publications and will not be unreasonably withheld.
- Publication restrictions are in place
Restriction type: OTHER