Trial Outcomes & Findings for A Study to Evaluate the Safety, Pharmacokinetics and Efficacy of the Combination of AL-335, Odalasvir, and Simeprevir (NCT NCT02569710)
NCT ID: NCT02569710
Last Updated: 2019-07-16
Results Overview
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent were events between administration of study drug and up to 43 weeks that were absent before treatment or that worsened relative to pre-treatment state.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
161 participants
Primary outcome timeframe
Up to 43 weeks
Results posted on
2019-07-16
Participant Flow
No participants were recruited for Cohorts 10 and 12, hence no data is reported here for these two cohorts.
Participant milestones
| Measure |
Cohort 1 (8 Weeks Genotype [GT1])
Cohort 1 (Participants without Cirrhosis) received single dose of AL-335 400 milligrams (mg) tablets once daily (QD), odalasvir (ODV) 50 mg tablet and simeprevir 100 mg tablet QD for 8 weeks.
|
Cohort 1b + Cohort 4 (8 Weeks GT1)
Cohort 1b (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets every other day (QOD) for 8 weeks; Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 8 weeks.
|
Cohort 2 (8 Weeks GT1)
Cohort 2 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
|
Cohort 3 (6 Weeks GT1)
Cohort 3 (Participants without Cirrhosis) received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD for 6 weeks.
|
Cohort 4 (12 Weeks GT1)
Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 12 weeks.
|
Cohort 5a (8 Weeks GT3)
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
|
Cohort 5b (12 Weeks GT3)
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 12 weeks.
|
Cohort 6,7,8 (8 Weeks GT1 F4)
Cohort 6 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks; Cohort 7 and Cohort 8 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 8 weeks.
|
Cohort 9 (12 Weeks GT1 F4)
Cohort 9 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
|
Cohort 11 (12 Weeks GT2 F4)
Cohort 11 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
20
|
25
|
20
|
20
|
8
|
5
|
14
|
30
|
15
|
4
|
|
Overall Study
COMPLETED
|
19
|
25
|
20
|
20
|
7
|
4
|
12
|
30
|
14
|
4
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
0
|
1
|
1
|
2
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
Cohort 1 (8 Weeks Genotype [GT1])
Cohort 1 (Participants without Cirrhosis) received single dose of AL-335 400 milligrams (mg) tablets once daily (QD), odalasvir (ODV) 50 mg tablet and simeprevir 100 mg tablet QD for 8 weeks.
|
Cohort 1b + Cohort 4 (8 Weeks GT1)
Cohort 1b (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets every other day (QOD) for 8 weeks; Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 8 weeks.
|
Cohort 2 (8 Weeks GT1)
Cohort 2 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
|
Cohort 3 (6 Weeks GT1)
Cohort 3 (Participants without Cirrhosis) received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD for 6 weeks.
|
Cohort 4 (12 Weeks GT1)
Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 12 weeks.
|
Cohort 5a (8 Weeks GT3)
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
|
Cohort 5b (12 Weeks GT3)
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 12 weeks.
|
Cohort 6,7,8 (8 Weeks GT1 F4)
Cohort 6 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks; Cohort 7 and Cohort 8 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 8 weeks.
|
Cohort 9 (12 Weeks GT1 F4)
Cohort 9 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
|
Cohort 11 (12 Weeks GT2 F4)
Cohort 11 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
1
|
0
|
|
Overall Study
Virologic failure
|
0
|
0
|
0
|
0
|
1
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
A Study to Evaluate the Safety, Pharmacokinetics and Efficacy of the Combination of AL-335, Odalasvir, and Simeprevir
Baseline characteristics by cohort
| Measure |
Cohort 1 (8 Weeks Genotype [GT1])
n=20 Participants
Cohort 1 (Participants without Cirrhosis) received single dose of AL-335 400 milligrams (mg) tablets once daily (QD), odalasvir (ODV) 50 mg tablet and simeprevir 100 mg tablet QD for 8 weeks.
|
Cohort 1b + Cohort 4 (8 Weeks GT1)
n=25 Participants
Cohort 1b (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets every other day (QOD) for 8 weeks; Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 8 weeks.
|
Cohort 2 (8 Weeks GT1)
n=20 Participants
Cohort 2 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
|
Cohort 3 (6 Weeks GT1)
n=20 Participants
Cohort 3 (Participants without Cirrhosis) received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD for 6 weeks.
|
Cohort 4 (12 Weeks GT1)
n=8 Participants
Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 12 weeks.
|
Cohort 5a (8 Weeks GT3)
n=5 Participants
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
|
Cohort 5b (12 Weeks GT3)
n=14 Participants
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 12 weeks.
|
Cohort 6,7,8 (8 Weeks GT1 F4)
n=30 Participants
Cohort 6 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks; Cohort 7 and Cohort 8 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 8 weeks.
|
Cohort 9 (12 Weeks GT1 F4)
n=15 Participants
Cohort 9 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
|
Cohort 11 (12 Weeks GT2 F4)
n=4 Participants
Cohort 11 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
|
Total
n=161 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
56 years
n=5 Participants
|
55 years
n=7 Participants
|
56 years
n=5 Participants
|
55.5 years
n=4 Participants
|
55 years
n=21 Participants
|
54 years
n=8 Participants
|
44.5 years
n=8 Participants
|
56.5 years
n=24 Participants
|
52 years
n=42 Participants
|
63.5 years
n=42 Participants
|
55 years
n=42 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
16 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
54 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
13 Participants
n=8 Participants
|
14 Participants
n=24 Participants
|
13 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
107 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
White
|
20 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
12 Participants
n=8 Participants
|
27 Participants
n=24 Participants
|
9 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
128 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
13 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or other Pacific Islander
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
10 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
5 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
8 Participants
n=42 Participants
|
|
Region of Enrollment
United Kingdom
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
|
Region of Enrollment
Moldova
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
13 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
16 Participants
n=42 Participants
|
|
Region of Enrollment
Mauritius
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
6 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
8 Participants
n=42 Participants
|
|
Region of Enrollment
New Zealand
|
20 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
14 Participants
n=8 Participants
|
14 Participants
n=24 Participants
|
5 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
134 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: Up to 43 weeksPopulation: Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent were events between administration of study drug and up to 43 weeks that were absent before treatment or that worsened relative to pre-treatment state.
Outcome measures
| Measure |
Cohort 1 (8 Weeks Genotype [GT1])
n=20 Participants
Cohort 1 (Participants without Cirrhosis) received single dose of AL-335 400 milligrams (mg) tablets once daily (QD), odalasvir (ODV) 50 mg tablet and simeprevir 100 mg tablet QD for 8 weeks.
|
Cohort 1b + Cohort 4 (8 Weeks GT1)
n=25 Participants
Cohort 1b (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets every other day (QOD) for 8 weeks; Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 8 weeks.
|
Cohort 2 (8 Weeks GT1)
n=20 Participants
Cohort 2 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
|
Cohort 3 (6 Weeks GT1)
n=20 Participants
Cohort 3 (Participants without Cirrhosis) received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD for 6 weeks.
|
Cohort 4 (12 Weeks GT1)
n=8 Participants
Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 12 weeks.
|
Cohort 5a (8 Weeks GT3)
n=5 Participants
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
|
Cohort 5b (12 Weeks GT3)
n=14 Participants
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 12 weeks.
|
Cohort 6,7,8 (8 Weeks GT1 F4)
n=30 Participants
Cohort 6 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks; Cohort 7 and Cohort 8 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 8 weeks.
|
Cohort 9 (12 Weeks GT1 F4)
n=15 Participants
Cohort 9 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
|
Cohort 11 (12 Weeks GT2 F4)
n=4 Participants
Cohort 11 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Event (TEAE)
|
17 Participants
|
19 Participants
|
14 Participants
|
13 Participants
|
7 Participants
|
4 Participants
|
13 Participants
|
17 Participants
|
10 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: End of treatment (Cohort 3: 6 weeks; Cohort 1, Cohort 1b+ Cohort 4, Cohort 2, Cohort 5a, and Cohort 6, 7, 8: 8 weeks; Cohort 4, Cohort 5b, Cohort 9 and Cohort 11: 12 weeks)Population: Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not. Here, N (number of participants analyzed) signifies number of participants evaluable for this endpoint.
Body weight (measured using a calibrated scale) at end of treatment was reported.
Outcome measures
| Measure |
Cohort 1 (8 Weeks Genotype [GT1])
n=19 Participants
Cohort 1 (Participants without Cirrhosis) received single dose of AL-335 400 milligrams (mg) tablets once daily (QD), odalasvir (ODV) 50 mg tablet and simeprevir 100 mg tablet QD for 8 weeks.
|
Cohort 1b + Cohort 4 (8 Weeks GT1)
n=25 Participants
Cohort 1b (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets every other day (QOD) for 8 weeks; Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 8 weeks.
|
Cohort 2 (8 Weeks GT1)
n=20 Participants
Cohort 2 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
|
Cohort 3 (6 Weeks GT1)
n=20 Participants
Cohort 3 (Participants without Cirrhosis) received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD for 6 weeks.
|
Cohort 4 (12 Weeks GT1)
n=8 Participants
Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 12 weeks.
|
Cohort 5a (8 Weeks GT3)
n=5 Participants
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
|
Cohort 5b (12 Weeks GT3)
n=14 Participants
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 12 weeks.
|
Cohort 6,7,8 (8 Weeks GT1 F4)
n=30 Participants
Cohort 6 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks; Cohort 7 and Cohort 8 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 8 weeks.
|
Cohort 9 (12 Weeks GT1 F4)
n=15 Participants
Cohort 9 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
|
Cohort 11 (12 Weeks GT2 F4)
n=4 Participants
Cohort 11 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Body Weight at End of Treatment
|
76.02 Kilograms (kg)
Standard Deviation 15.13
|
84.58 Kilograms (kg)
Standard Deviation 15.09
|
80.19 Kilograms (kg)
Standard Deviation 17.79
|
74.07 Kilograms (kg)
Standard Deviation 12.78
|
73.09 Kilograms (kg)
Standard Deviation 8.62
|
81.30 Kilograms (kg)
Standard Deviation 13.82
|
81.83 Kilograms (kg)
Standard Deviation 13.67
|
80.15 Kilograms (kg)
Standard Deviation 17.92
|
86.02 Kilograms (kg)
Standard Deviation 15.56
|
69.90 Kilograms (kg)
Standard Deviation 11.55
|
PRIMARY outcome
Timeframe: End of treatment (Cohort 3: 6 weeks; Cohort 1, Cohort 1b+ Cohort 4, Cohort 2, Cohort 5a, and Cohort 6, 7, 8: 8 weeks; Cohort 4, Cohort 5b, Cohort 9 and Cohort 11: 12 weeks)Population: Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not. Here, N (number of participants analyzed) signifies number of participants evaluable for this endpoint.
BMI was calculated by dividing the body weight (in kilogram) by the square of height (in meters). BMI at end of treatment was reported.
Outcome measures
| Measure |
Cohort 1 (8 Weeks Genotype [GT1])
n=19 Participants
Cohort 1 (Participants without Cirrhosis) received single dose of AL-335 400 milligrams (mg) tablets once daily (QD), odalasvir (ODV) 50 mg tablet and simeprevir 100 mg tablet QD for 8 weeks.
|
Cohort 1b + Cohort 4 (8 Weeks GT1)
n=25 Participants
Cohort 1b (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets every other day (QOD) for 8 weeks; Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 8 weeks.
|
Cohort 2 (8 Weeks GT1)
n=20 Participants
Cohort 2 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
|
Cohort 3 (6 Weeks GT1)
n=20 Participants
Cohort 3 (Participants without Cirrhosis) received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD for 6 weeks.
|
Cohort 4 (12 Weeks GT1)
n=8 Participants
Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 12 weeks.
|
Cohort 5a (8 Weeks GT3)
n=5 Participants
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
|
Cohort 5b (12 Weeks GT3)
n=14 Participants
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 12 weeks.
|
Cohort 6,7,8 (8 Weeks GT1 F4)
n=30 Participants
Cohort 6 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks; Cohort 7 and Cohort 8 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 8 weeks.
|
Cohort 9 (12 Weeks GT1 F4)
n=15 Participants
Cohort 9 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
|
Cohort 11 (12 Weeks GT2 F4)
n=4 Participants
Cohort 11 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Body Mass Index (BMI) at End of Treatment
|
25.89 Kilograms per square meter (Kg/m^2)
Standard Deviation 4.63
|
28.43 Kilograms per square meter (Kg/m^2)
Standard Deviation 4.26
|
26.45 Kilograms per square meter (Kg/m^2)
Standard Deviation 5.53
|
25.46 Kilograms per square meter (Kg/m^2)
Standard Deviation 3.53
|
25.60 Kilograms per square meter (Kg/m^2)
Standard Deviation 3.21
|
25.60 Kilograms per square meter (Kg/m^2)
Standard Deviation 2.82
|
26.17 Kilograms per square meter (Kg/m^2)
Standard Deviation 4.20
|
27.69 Kilograms per square meter (Kg/m^2)
Standard Deviation 5.28
|
27.98 Kilograms per square meter (Kg/m^2)
Standard Deviation 4.37
|
23.64 Kilograms per square meter (Kg/m^2)
Standard Deviation 4.50
|
PRIMARY outcome
Timeframe: Up to 43 weeksPopulation: Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
Percentage of participants with worst post-baseline values of vital signs (Systolic blood pressure \[sBP\], Diastolic blood pressure \[dBP\], and Heart rate) were reported. For sBP, abnormally low: less than or equal to \[\<=\] 90 millimeters mercury \[mmHg\]; Grade 1 or mild: greater than \[\>\] 140 to less than \[\<\] 160 mmHg; Grade 2 or moderate: \>=160 to \<180 and Grade 3 or severe: \>=180 mmHg. For dBP, abnormally low: \<=50 mmHg; Grade 1 or mild: \>90 to \<100 mmHg; Grade 2 or moderate: \>=100 to \<110 mmHg and Grade 3 or severe: \>=110 mmHg. For Heart Rate, abnormally low: \<=50 beats per minute \[bpm\] and abnormally high: \>=120 bpm.
Outcome measures
| Measure |
Cohort 1 (8 Weeks Genotype [GT1])
n=20 Participants
Cohort 1 (Participants without Cirrhosis) received single dose of AL-335 400 milligrams (mg) tablets once daily (QD), odalasvir (ODV) 50 mg tablet and simeprevir 100 mg tablet QD for 8 weeks.
|
Cohort 1b + Cohort 4 (8 Weeks GT1)
n=25 Participants
Cohort 1b (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets every other day (QOD) for 8 weeks; Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 8 weeks.
|
Cohort 2 (8 Weeks GT1)
n=20 Participants
Cohort 2 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
|
Cohort 3 (6 Weeks GT1)
n=20 Participants
Cohort 3 (Participants without Cirrhosis) received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD for 6 weeks.
|
Cohort 4 (12 Weeks GT1)
n=8 Participants
Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 12 weeks.
|
Cohort 5a (8 Weeks GT3)
n=5 Participants
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
|
Cohort 5b (12 Weeks GT3)
n=14 Participants
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 12 weeks.
|
Cohort 6,7,8 (8 Weeks GT1 F4)
n=30 Participants
Cohort 6 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks; Cohort 7 and Cohort 8 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 8 weeks.
|
Cohort 9 (12 Weeks GT1 F4)
n=15 Participants
Cohort 9 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
|
Cohort 11 (12 Weeks GT2 F4)
n=4 Participants
Cohort 11 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Worst Post-Baseline Values of Vital Signs
sBP: Abnormally low
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
3.3 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants With Worst Post-Baseline Values of Vital Signs
sBP: Grade 1 or mild
|
20.0 Percentage of participants
|
32.0 Percentage of participants
|
35.0 Percentage of participants
|
25.0 Percentage of participants
|
37.5 Percentage of participants
|
60.0 Percentage of participants
|
57.1 Percentage of participants
|
26.7 Percentage of participants
|
46.7 Percentage of participants
|
25.0 Percentage of participants
|
|
Percentage of Participants With Worst Post-Baseline Values of Vital Signs
sBP: Grade 2 or moderate
|
10.0 Percentage of participants
|
8.0 Percentage of participants
|
0 Percentage of participants
|
5.0 Percentage of participants
|
37.5 Percentage of participants
|
0 Percentage of participants
|
7.1 Percentage of participants
|
20.0 Percentage of participants
|
13.3 Percentage of participants
|
50.0 Percentage of participants
|
|
Percentage of Participants With Worst Post-Baseline Values of Vital Signs
sBP: Grade 3 or severe
|
0 Percentage of participants
|
4.0 Percentage of participants
|
5.0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
3.3 Percentage of participants
|
13.3 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants With Worst Post-Baseline Values of Vital Signs
dBP: Abnormally low
|
0 Percentage of participants
|
4.0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
12.5 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants With Worst Post-Baseline Values of Vital Signs
dBP: Grade 2 or moderate
|
5.0 Percentage of participants
|
12.0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
14.3 Percentage of participants
|
13.3 Percentage of participants
|
6.7 Percentage of participants
|
25.0 Percentage of participants
|
|
Percentage of Participants With Worst Post-Baseline Values of Vital Signs
dBP: Grade 3 or severe
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
25.0 Percentage of participants
|
0 Percentage of participants
|
7.1 Percentage of participants
|
3.3 Percentage of participants
|
6.7 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants With Worst Post-Baseline Values of Vital Signs
Heart Rate: Abnormally low
|
35.0 Percentage of participants
|
32.0 Percentage of participants
|
35.0 Percentage of participants
|
30.0 Percentage of participants
|
50.0 Percentage of participants
|
20.0 Percentage of participants
|
21.4 Percentage of participants
|
13.3 Percentage of participants
|
13.3 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants With Worst Post-Baseline Values of Vital Signs
Heart Rate: Abnormally high
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
12.5 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants With Worst Post-Baseline Values of Vital Signs
dBP: Grade 1 or mild
|
5.0 Percentage of participants
|
20.0 Percentage of participants
|
35.0 Percentage of participants
|
20.0 Percentage of participants
|
0 Percentage of participants
|
60.0 Percentage of participants
|
21.4 Percentage of participants
|
10.0 Percentage of participants
|
26.7 Percentage of participants
|
0 Percentage of participants
|
PRIMARY outcome
Timeframe: Baseline up to End of treatment (up to 43 weeks)Population: Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
Percentage of participants with maximum decrease from baseline in mean ejection fraction was reported. Percentages are based on the number of participants with available data.
Outcome measures
| Measure |
Cohort 1 (8 Weeks Genotype [GT1])
n=20 Participants
Cohort 1 (Participants without Cirrhosis) received single dose of AL-335 400 milligrams (mg) tablets once daily (QD), odalasvir (ODV) 50 mg tablet and simeprevir 100 mg tablet QD for 8 weeks.
|
Cohort 1b + Cohort 4 (8 Weeks GT1)
n=25 Participants
Cohort 1b (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets every other day (QOD) for 8 weeks; Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 8 weeks.
|
Cohort 2 (8 Weeks GT1)
n=20 Participants
Cohort 2 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
|
Cohort 3 (6 Weeks GT1)
n=20 Participants
Cohort 3 (Participants without Cirrhosis) received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD for 6 weeks.
|
Cohort 4 (12 Weeks GT1)
n=8 Participants
Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 12 weeks.
|
Cohort 5a (8 Weeks GT3)
n=5 Participants
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
|
Cohort 5b (12 Weeks GT3)
n=14 Participants
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 12 weeks.
|
Cohort 6,7,8 (8 Weeks GT1 F4)
n=30 Participants
Cohort 6 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks; Cohort 7 and Cohort 8 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 8 weeks.
|
Cohort 9 (12 Weeks GT1 F4)
n=15 Participants
Cohort 9 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
|
Cohort 11 (12 Weeks GT2 F4)
n=4 Participants
Cohort 11 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Maximum Decrease From Baseline in Mean Ejection Fraction
Decline of >5-<=10%
|
0.0 Percentage of participants
|
4.0 Percentage of participants
|
10.0 Percentage of participants
|
10.0 Percentage of participants
|
12.5 Percentage of participants
|
0.0 Percentage of participants
|
21.4 Percentage of participants
|
3.3 Percentage of participants
|
6.7 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Maximum Decrease From Baseline in Mean Ejection Fraction
Decline of >0-<=5%
|
65.0 Percentage of participants
|
48.0 Percentage of participants
|
60.0 Percentage of participants
|
50.0 Percentage of participants
|
50.0 Percentage of participants
|
20.0 Percentage of participants
|
64.3 Percentage of participants
|
80.0 Percentage of participants
|
46.7 Percentage of participants
|
50.0 Percentage of participants
|
|
Percentage of Participants With Maximum Decrease From Baseline in Mean Ejection Fraction
Decline of > 10%
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
PRIMARY outcome
Timeframe: Up to 43 weeksPopulation: Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
Percentage of participants by treatment emergent toxicity grade (1, 2, 3, 4 and 3+4) for Hematology parameters (hemoglobin, lymphocytes, neutrophils, leukocytes, platelets) were reported. Toxicity grades were defined as Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe and Grade 4: potentially life-threatening. A toxicity is treatment-emergent if it is worse than the baseline or if baseline is missing.
Outcome measures
| Measure |
Cohort 1 (8 Weeks Genotype [GT1])
n=20 Participants
Cohort 1 (Participants without Cirrhosis) received single dose of AL-335 400 milligrams (mg) tablets once daily (QD), odalasvir (ODV) 50 mg tablet and simeprevir 100 mg tablet QD for 8 weeks.
|
Cohort 1b + Cohort 4 (8 Weeks GT1)
n=25 Participants
Cohort 1b (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets every other day (QOD) for 8 weeks; Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 8 weeks.
|
Cohort 2 (8 Weeks GT1)
n=20 Participants
Cohort 2 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
|
Cohort 3 (6 Weeks GT1)
n=20 Participants
Cohort 3 (Participants without Cirrhosis) received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD for 6 weeks.
|
Cohort 4 (12 Weeks GT1)
n=8 Participants
Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 12 weeks.
|
Cohort 5a (8 Weeks GT3)
n=5 Participants
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
|
Cohort 5b (12 Weeks GT3)
n=14 Participants
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 12 weeks.
|
Cohort 6,7,8 (8 Weeks GT1 F4)
n=30 Participants
Cohort 6 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks; Cohort 7 and Cohort 8 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 8 weeks.
|
Cohort 9 (12 Weeks GT1 F4)
n=15 Participants
Cohort 9 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
|
Cohort 11 (12 Weeks GT2 F4)
n=4 Participants
Cohort 11 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters
Hemoglobin: Grade 1
|
5.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
5.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters
Hemoglobin: Grade 2
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters
Hemoglobin: Grade 4
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters
Lymphocytes: Grade 2
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
7.1 Percentage of participants
|
10.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters
Lymphocytes: Grade 3+4
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters
Neutrophils: Grade 1
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
3.3 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters
Neutrophils: Grade 3
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters
Neutrophils: Grade 4
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters
Leukocytes: Grade 1
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
10.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters
Leukocytes: Grade 2
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters
Leukocytes: Grade 3
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters
Leukocytes: Grade 4
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters
Leukocytes: Grade 3+4
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters
Platelets: Grade 1
|
5.0 Percentage of participants
|
0.0 Percentage of participants
|
5.0 Percentage of participants
|
5.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
7.1 Percentage of participants
|
6.7 Percentage of participants
|
13.3 Percentage of participants
|
25.0 Percentage of participants
|
|
Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters
Platelets: Grade 2
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
16.7 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters
Platelets: Grade 3
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters
Platelets: Grade 3+4
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters
Hemoglobin: Grade 3
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters
Hemoglobin: Grade 3+4
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters
Lymphocytes: Grade 1
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
6.7 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters
Lymphocytes: Grade 3
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters
Lymphocytes: Grade 4
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters
Neutrophils: Grade 2
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters
Neutrophils: Grade 3+4
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters
Platelets: Grade 4
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
PRIMARY outcome
Timeframe: Up to 43 weeksPopulation: Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
Percentage of participants by treatment emergent toxicity grade (Grade 1,2,3,4,3+4) for Blood Chemistry (Calcium, Phosphate, Potassium, Sodium, Bicarbonate, Alanine aminotransferase, Alkaline phosphatase, Aspartate aminotransferase, Bilirubin, Direct bilirubin, Glucose, Cholesterol, Triglycerides, Urate, Triacylglycerol lipase, Creatinine, Creatinine clearance, Albumin and Creatine kinase) were reported. Toxicity grades were defined as Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe and Grade 4: potentially life-threatening. A toxicity is treatment-emergent if it is worse than the baseline or if baseline is missing.
Outcome measures
| Measure |
Cohort 1 (8 Weeks Genotype [GT1])
n=20 Participants
Cohort 1 (Participants without Cirrhosis) received single dose of AL-335 400 milligrams (mg) tablets once daily (QD), odalasvir (ODV) 50 mg tablet and simeprevir 100 mg tablet QD for 8 weeks.
|
Cohort 1b + Cohort 4 (8 Weeks GT1)
n=25 Participants
Cohort 1b (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets every other day (QOD) for 8 weeks; Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 8 weeks.
|
Cohort 2 (8 Weeks GT1)
n=20 Participants
Cohort 2 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
|
Cohort 3 (6 Weeks GT1)
n=20 Participants
Cohort 3 (Participants without Cirrhosis) received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD for 6 weeks.
|
Cohort 4 (12 Weeks GT1)
n=8 Participants
Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 12 weeks.
|
Cohort 5a (8 Weeks GT3)
n=5 Participants
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
|
Cohort 5b (12 Weeks GT3)
n=14 Participants
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 12 weeks.
|
Cohort 6,7,8 (8 Weeks GT1 F4)
n=30 Participants
Cohort 6 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks; Cohort 7 and Cohort 8 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 8 weeks.
|
Cohort 9 (12 Weeks GT1 F4)
n=15 Participants
Cohort 9 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
|
Cohort 11 (12 Weeks GT2 F4)
n=4 Participants
Cohort 11 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters
Potassium: Grade 4
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters
Phosphate: Grade 1
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters
Alanine aminotransferase: Grade 3+4
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
6.7 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters
Calcium: Grade 1
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
3.3 Percentage of participants
|
13.3 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters
Calcium: Grade 2
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters
Calcium: Grade 3
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters
Calcium: Grade 4
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters
Calcium: Grade 3+4
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters
Phosphate: Grade 2
|
10.0 Percentage of participants
|
20.0 Percentage of participants
|
25.0 Percentage of participants
|
15.0 Percentage of participants
|
12.5 Percentage of participants
|
0.0 Percentage of participants
|
14.3 Percentage of participants
|
13.3 Percentage of participants
|
6.7 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters
Phosphate: Grade 3
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
21.4 Percentage of participants
|
3.3 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters
Phosphate: Grade 4
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters
Phosphate: Grade 3+4
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
21.4 Percentage of participants
|
3.3 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters
Potassium: Grade 1
|
0.0 Percentage of participants
|
4.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
6.7 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters
Potassium: Grade 2
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters
Potassium: Grade 3
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters
Potassium: Grade 3+4
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters
Sodium: Grade 1
|
0.0 Percentage of participants
|
8.0 Percentage of participants
|
5.0 Percentage of participants
|
0.0 Percentage of participants
|
12.5 Percentage of participants
|
20.0 Percentage of participants
|
0.0 Percentage of participants
|
3.3 Percentage of participants
|
20.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters
Sodium: Grade 2
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters
Sodium: Grade 3
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters
Sodium: Grade 4
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters
Sodium: Grade 3+4
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters
Bicarbonate: Grade 1
|
0.0 Percentage of participants
|
16.0 Percentage of participants
|
15.0 Percentage of participants
|
5.0 Percentage of participants
|
12.5 Percentage of participants
|
20.0 Percentage of participants
|
7.1 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters
Bicarbonate: Grade 2
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
6.7 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters
Alkaline phosphatase: Grade 1
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
6.7 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters
Bicarbonate: Grade 3
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters
Bicarbonate: Grade 4
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters
Bicarbonate: Grade 3+4
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters
Alanine aminotransferase: Grade 1
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
3.3 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters
Alanine aminotransferase: Grade 2
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters
Alanine aminotransferase: Grade 4
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
6.7 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters
Alkaline phosphatase: Grade 2
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters
Alkaline phosphatase: Grade 3
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters
Alkaline phosphatase: Grade 4
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters
Alkaline phosphatase: Grade 3+4
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters
Aspartate aminotransferase: Grade: 1
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
25.0 Percentage of participants
|
|
Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters
Aspartate aminotransferase: Grade: 2
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
3.3 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters
Aspartate aminotransferase: Grade: 3
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
6.7 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters
Aspartate aminotransferase: Grade: 4
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters
Aspartate aminotransferase: Grade: 3+4
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
6.7 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters
Bilirubin: Grade 2
|
5.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
3.3 Percentage of participants
|
0.0 Percentage of participants
|
25.0 Percentage of participants
|
|
Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters
Bilirubin: Grade 3
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
3.3 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters
Bilirubin: Grade 4
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters
Bilirubin: Grade 3+4
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
3.3 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters
Direct bilirubin: Grade 1
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters
Direct bilirubin: Grade 2
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters
Direct bilirubin: Grade 3
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
3.3 Percentage of participants
|
6.7 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters
Direct bilirubin: Grade 4
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters
Direct bilirubin: Grade 3+4
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
3.3 Percentage of participants
|
6.7 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters
Glucose: Grade 1
|
15.0 Percentage of participants
|
4.0 Percentage of participants
|
10.0 Percentage of participants
|
5.0 Percentage of participants
|
25.0 Percentage of participants
|
0.0 Percentage of participants
|
35.7 Percentage of participants
|
10.0 Percentage of participants
|
13.3 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters
Glucose: Grade 2
|
0.0 Percentage of participants
|
4.0 Percentage of participants
|
5.0 Percentage of participants
|
0.0 Percentage of participants
|
12.5 Percentage of participants
|
0.0 Percentage of participants
|
14.3 Percentage of participants
|
13.3 Percentage of participants
|
13.3 Percentage of participants
|
25.0 Percentage of participants
|
|
Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters
Glucose: Grade 4
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters
Glucose: Grade 3+4
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
3.3 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters
Cholesterol: Grade 3
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
5.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
3.3 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters
Cholesterol: Grade 3+4
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
5.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
3.3 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters
Triglycerides: Grade 1
|
5.0 Percentage of participants
|
16.0 Percentage of participants
|
10.0 Percentage of participants
|
15.0 Percentage of participants
|
50.0 Percentage of participants
|
20.0 Percentage of participants
|
28.6 Percentage of participants
|
16.7 Percentage of participants
|
33.3 Percentage of participants
|
25.0 Percentage of participants
|
|
Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters
Triglycerides: Grade 2
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
14.3 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters
Triglycerides: Grade 4
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters
Triglycerides: Grade 3+4
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters
Urate: Grade 1
|
5.0 Percentage of participants
|
12.0 Percentage of participants
|
5.0 Percentage of participants
|
0.0 Percentage of participants
|
12.5 Percentage of participants
|
0.0 Percentage of participants
|
28.6 Percentage of participants
|
10.0 Percentage of participants
|
26.7 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters
Urate: Grade 2
|
0.0 Percentage of participants
|
4.0 Percentage of participants
|
0.0 Percentage of participants
|
5.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
3.3 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters
Urate: Grade 4
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters
Triacylglycerol lipase: Grade 1
|
5.0 Percentage of participants
|
12.0 Percentage of participants
|
5.0 Percentage of participants
|
0.0 Percentage of participants
|
12.5 Percentage of participants
|
20.0 Percentage of participants
|
7.1 Percentage of participants
|
13.3 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters
Triacylglycerol lipase: Grade 4
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
5.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters
Triacylglycerol lipase: Grade 3+4
|
5.0 Percentage of participants
|
8.0 Percentage of participants
|
5.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters
Creatinine: Grade 1
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters
Creatinine: Grade 4
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters
Creatinine: Grade 3+4
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
12.5 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
3.3 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters
Creatinine clearance: Grade 1
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters
Creatinine clearance: Grade 4
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters
Creatinine clearance: Grade 3+4
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters
Albumin: Grade 1
|
5.0 Percentage of participants
|
4.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
25.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters
Albumin: Grade 3
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters
Albumin: Grade 4
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters
Albumin: Grade 3+4
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters
Creatine kinase: Grade 1
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
7.1 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters
Creatine kinase: Grade 2
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
6.7 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters
Creatine kinase: Grade 3
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters
Creatine kinase: Grade 4
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters
Creatine kinase: Grade 3+4
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters
Bilirubin: Grade 1
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
10.0 Percentage of participants
|
10.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
3.3 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters
Glucose: Grade 3
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
3.3 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters
Cholesterol: Grade 1
|
20.0 Percentage of participants
|
24.0 Percentage of participants
|
30.0 Percentage of participants
|
35.0 Percentage of participants
|
12.5 Percentage of participants
|
0.0 Percentage of participants
|
42.9 Percentage of participants
|
3.3 Percentage of participants
|
20.0 Percentage of participants
|
50.0 Percentage of participants
|
|
Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters
Cholesterol: Grade 2
|
15.0 Percentage of participants
|
8.0 Percentage of participants
|
5.0 Percentage of participants
|
5.0 Percentage of participants
|
37.5 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
6.7 Percentage of participants
|
6.7 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters
Cholesterol: Grade 4
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters
Triglycerides: Grade 3
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters
Urate: Grade 3
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters
Urate: Grade 3+4
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters
Triacylglycerol lipase: Grade 2
|
15.0 Percentage of participants
|
4.0 Percentage of participants
|
10.0 Percentage of participants
|
0.0 Percentage of participants
|
12.5 Percentage of participants
|
0.0 Percentage of participants
|
7.1 Percentage of participants
|
3.3 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters
Triacylglycerol lipase: Grade 3
|
5.0 Percentage of participants
|
8.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters
Creatinine clearance: Grade 2
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
20.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters
Creatinine: Grade 2
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
5.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
7.1 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters
Creatinine: Grade 3
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
12.5 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
3.3 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters
Creatinine clearance: Grade 3
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters
Albumin: Grade 2
|
0.0 Percentage of participants
|
8.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters
Alanine aminotransferase: Grade 3
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
PRIMARY outcome
Timeframe: Up to 43 weeksPopulation: Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
Percentage of participants by treatment emergent toxicity grade for coagulation parameter (Prothrombin International Normalized Ratio) were reported. Toxicity grades were defined as Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe and Grade 4: potentially life-threatening. A toxicity is treatment-emergent if it is worse than the baseline or if baseline is missing.
Outcome measures
| Measure |
Cohort 1 (8 Weeks Genotype [GT1])
n=20 Participants
Cohort 1 (Participants without Cirrhosis) received single dose of AL-335 400 milligrams (mg) tablets once daily (QD), odalasvir (ODV) 50 mg tablet and simeprevir 100 mg tablet QD for 8 weeks.
|
Cohort 1b + Cohort 4 (8 Weeks GT1)
n=25 Participants
Cohort 1b (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets every other day (QOD) for 8 weeks; Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 8 weeks.
|
Cohort 2 (8 Weeks GT1)
n=20 Participants
Cohort 2 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
|
Cohort 3 (6 Weeks GT1)
n=20 Participants
Cohort 3 (Participants without Cirrhosis) received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD for 6 weeks.
|
Cohort 4 (12 Weeks GT1)
n=8 Participants
Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 12 weeks.
|
Cohort 5a (8 Weeks GT3)
n=5 Participants
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
|
Cohort 5b (12 Weeks GT3)
n=14 Participants
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 12 weeks.
|
Cohort 6,7,8 (8 Weeks GT1 F4)
n=30 Participants
Cohort 6 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks; Cohort 7 and Cohort 8 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 8 weeks.
|
Cohort 9 (12 Weeks GT1 F4)
n=15 Participants
Cohort 9 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
|
Cohort 11 (12 Weeks GT2 F4)
n=4 Participants
Cohort 11 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants by Treatment Emergent Toxicity Grade - Prothrombin International Normalized Ratio (INR)
Prothrombin INR: Grade 3
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants by Treatment Emergent Toxicity Grade - Prothrombin International Normalized Ratio (INR)
Prothrombin INR: Grade 4
|
0.0 Percentage of participants
|
4.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants by Treatment Emergent Toxicity Grade - Prothrombin International Normalized Ratio (INR)
Prothrombin INR: Grade 3+4
|
0.0 Percentage of participants
|
4.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants by Treatment Emergent Toxicity Grade - Prothrombin International Normalized Ratio (INR)
Prothrombin INR: Grade 1
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants by Treatment Emergent Toxicity Grade - Prothrombin International Normalized Ratio (INR)
Prothrombin INR: Grade 2
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
PRIMARY outcome
Timeframe: Up to 43 weeksPopulation: Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
Percentage of participants by treatment emergent toxicity grade (Grade 1, 2, 3, 4, 3+4) for urinalysis parameter (protein) was reported. Toxicity grades were defined as Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe and Grade 4: potentially life-threatening. A toxicity is treatment-emergent if it is worse than the baseline or if baseline is missing.
Outcome measures
| Measure |
Cohort 1 (8 Weeks Genotype [GT1])
n=20 Participants
Cohort 1 (Participants without Cirrhosis) received single dose of AL-335 400 milligrams (mg) tablets once daily (QD), odalasvir (ODV) 50 mg tablet and simeprevir 100 mg tablet QD for 8 weeks.
|
Cohort 1b + Cohort 4 (8 Weeks GT1)
n=25 Participants
Cohort 1b (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets every other day (QOD) for 8 weeks; Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 8 weeks.
|
Cohort 2 (8 Weeks GT1)
n=20 Participants
Cohort 2 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
|
Cohort 3 (6 Weeks GT1)
n=20 Participants
Cohort 3 (Participants without Cirrhosis) received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD for 6 weeks.
|
Cohort 4 (12 Weeks GT1)
n=8 Participants
Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 12 weeks.
|
Cohort 5a (8 Weeks GT3)
n=5 Participants
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
|
Cohort 5b (12 Weeks GT3)
n=14 Participants
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 12 weeks.
|
Cohort 6,7,8 (8 Weeks GT1 F4)
n=30 Participants
Cohort 6 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks; Cohort 7 and Cohort 8 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 8 weeks.
|
Cohort 9 (12 Weeks GT1 F4)
n=15 Participants
Cohort 9 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
|
Cohort 11 (12 Weeks GT2 F4)
n=4 Participants
Cohort 11 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants by Treatment Emergent Toxicity Grade - Urinalysis Parameter (Protein)
Protein: Grade 2
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
13.3 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants by Treatment Emergent Toxicity Grade - Urinalysis Parameter (Protein)
Protein: Grade 3
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
3.3 Percentage of participants
|
0.0 Percentage of participants
|
25.0 Percentage of participants
|
|
Percentage of Participants by Treatment Emergent Toxicity Grade - Urinalysis Parameter (Protein)
Protein: Grade 4
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants by Treatment Emergent Toxicity Grade - Urinalysis Parameter (Protein)
Protein: Grade 3+4
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
3.3 Percentage of participants
|
0.0 Percentage of participants
|
25.0 Percentage of participants
|
|
Percentage of Participants by Treatment Emergent Toxicity Grade - Urinalysis Parameter (Protein)
Protein: Grade 1
|
0.0 Percentage of participants
|
4.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
7.1 Percentage of participants
|
3.3 Percentage of participants
|
26.7 Percentage of participants
|
50.0 Percentage of participants
|
PRIMARY outcome
Timeframe: Up to 43 weeksPopulation: Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
Percentage of participants with worst treatment emergent abnormalities of ECG parameters (Fridericia Corrected QT interval \[QTcF\], Bazett Corrected QT interval \[QTcB\], Heart rate, QRS and PR, was reported. For QTcF abnormality was defined as 30 milliseconds (ms) less than or equal to (\<=) QTcF increase from baseline \<= 60 ms; for QTcB abnormality was defined as 30 ms \<= QTcB increase from baseline \<= 60 ms; for heart rate - abnormal low: \<= 50 beats per minute (bpm) and abnormal high: \>= 120 bpm; for QRS - abnormal high: \>120 ms; for PR - abnormally low: PR \< 120 ms; abnormally high - 200 ms \< PR \<= 240 ms and 240 ms \< PR \<= 300 ms.
Outcome measures
| Measure |
Cohort 1 (8 Weeks Genotype [GT1])
n=20 Participants
Cohort 1 (Participants without Cirrhosis) received single dose of AL-335 400 milligrams (mg) tablets once daily (QD), odalasvir (ODV) 50 mg tablet and simeprevir 100 mg tablet QD for 8 weeks.
|
Cohort 1b + Cohort 4 (8 Weeks GT1)
n=25 Participants
Cohort 1b (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets every other day (QOD) for 8 weeks; Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 8 weeks.
|
Cohort 2 (8 Weeks GT1)
n=20 Participants
Cohort 2 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
|
Cohort 3 (6 Weeks GT1)
n=20 Participants
Cohort 3 (Participants without Cirrhosis) received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD for 6 weeks.
|
Cohort 4 (12 Weeks GT1)
n=8 Participants
Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 12 weeks.
|
Cohort 5a (8 Weeks GT3)
n=5 Participants
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
|
Cohort 5b (12 Weeks GT3)
n=14 Participants
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 12 weeks.
|
Cohort 6,7,8 (8 Weeks GT1 F4)
n=30 Participants
Cohort 6 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks; Cohort 7 and Cohort 8 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 8 weeks.
|
Cohort 9 (12 Weeks GT1 F4)
n=15 Participants
Cohort 9 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
|
Cohort 11 (12 Weeks GT2 F4)
n=4 Participants
Cohort 11 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Worst Treatment Emergent Abnormalities of Electrocardiogram (ECG) Parameters
QTcF: Abnormal
|
5.0 Percentage of participants
|
0.0 Percentage of participants
|
5.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
7.1 Percentage of participants
|
3.3 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Worst Treatment Emergent Abnormalities of Electrocardiogram (ECG) Parameters
QTcB: Abnormal
|
5.0 Percentage of participants
|
8.0 Percentage of participants
|
10.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
28.6 Percentage of participants
|
3.3 Percentage of participants
|
6.7 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Worst Treatment Emergent Abnormalities of Electrocardiogram (ECG) Parameters
Heart rate: Abnormal low
|
25.0 Percentage of participants
|
16.0 Percentage of participants
|
10.0 Percentage of participants
|
15.0 Percentage of participants
|
25.0 Percentage of participants
|
20.0 Percentage of participants
|
14.3 Percentage of participants
|
13.3 Percentage of participants
|
0.0 Percentage of participants
|
25.0 Percentage of participants
|
|
Percentage of Participants With Worst Treatment Emergent Abnormalities of Electrocardiogram (ECG) Parameters
Heart rate: Abnormal high
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
12.5 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Worst Treatment Emergent Abnormalities of Electrocardiogram (ECG) Parameters
QRS: Abnormal high
|
0.0 Percentage of participants
|
4.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Worst Treatment Emergent Abnormalities of Electrocardiogram (ECG) Parameters
PR: Abnormally low (PR<120 ms)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
7.1 Percentage of participants
|
3.3 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Worst Treatment Emergent Abnormalities of Electrocardiogram (ECG) Parameters
PR: Abnormally high (200 ms<PR<= 240 ms)
|
5.0 Percentage of participants
|
8.0 Percentage of participants
|
15.0 Percentage of participants
|
10.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
6.7 Percentage of participants
|
13.3 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Worst Treatment Emergent Abnormalities of Electrocardiogram (ECG) Parameters
PR: Abnormal high (240 ms<PR<=300 ms)
|
10.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
7.1 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
SECONDARY outcome
Timeframe: At Week 4, 12 and Week 24 after end of treatment (Cohort 3: 6 weeks; Cohort 1, Cohort 1b+ Cohort 4, Cohort 2, Cohort 5a, and Cohort 6, 7, 8: 8 weeks; Cohort 4, Cohort 5b, Cohort 9 and Cohort 11: 12 weeks)Population: Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
Participants were considered to have achieved SVR if the Hepatitis C virus (HCV) Ribonucleic acid (RNA) less than (\<) Lower limit of quantification (LLOQ) (\<15 international unit per milliliter \[IU/mL\]) detectable or undetectable at Week 4, 12 and 24 after the actual end of study drug treatment.
Outcome measures
| Measure |
Cohort 1 (8 Weeks Genotype [GT1])
n=20 Participants
Cohort 1 (Participants without Cirrhosis) received single dose of AL-335 400 milligrams (mg) tablets once daily (QD), odalasvir (ODV) 50 mg tablet and simeprevir 100 mg tablet QD for 8 weeks.
|
Cohort 1b + Cohort 4 (8 Weeks GT1)
n=25 Participants
Cohort 1b (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets every other day (QOD) for 8 weeks; Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 8 weeks.
|
Cohort 2 (8 Weeks GT1)
n=20 Participants
Cohort 2 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
|
Cohort 3 (6 Weeks GT1)
n=20 Participants
Cohort 3 (Participants without Cirrhosis) received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD for 6 weeks.
|
Cohort 4 (12 Weeks GT1)
n=8 Participants
Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 12 weeks.
|
Cohort 5a (8 Weeks GT3)
n=5 Participants
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
|
Cohort 5b (12 Weeks GT3)
n=14 Participants
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 12 weeks.
|
Cohort 6,7,8 (8 Weeks GT1 F4)
n=30 Participants
Cohort 6 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks; Cohort 7 and Cohort 8 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 8 weeks.
|
Cohort 9 (12 Weeks GT1 F4)
n=15 Participants
Cohort 9 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
|
Cohort 11 (12 Weeks GT2 F4)
n=4 Participants
Cohort 11 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Sustained Virologic Response (SVR) at Week 4, 12 and 24 After End of Treatment
4 weeks after end of treatment
|
100 Percentage of participants
Interval 83.2 to 100.0
|
96.0 Percentage of participants
Interval 79.6 to 99.9
|
100 Percentage of participants
Interval 83.2 to 100.0
|
100 Percentage of participants
Interval 83.2 to 100.0
|
87.5 Percentage of participants
Interval 47.3 to 99.7
|
0 Percentage of participants
NA indicates that upper and lower limit of confidence interval (CI) was not estimable as no participant achieved SVR in this group.
|
71.4 Percentage of participants
Interval 41.9 to 91.6
|
100 Percentage of participants
Interval 88.4 to 100.0
|
93.3 Percentage of participants
Interval 68.1 to 99.8
|
100 Percentage of participants
Interval 39.8 to 100.0
|
|
Percentage of Participants With Sustained Virologic Response (SVR) at Week 4, 12 and 24 After End of Treatment
12 weeks after end of treatment
|
100 Percentage of participants
Interval 83.2 to 100.0
|
84.0 Percentage of participants
Interval 63.9 to 95.5
|
100 Percentage of participants
Interval 83.2 to 100.0
|
100 Percentage of participants
Interval 83.2 to 100.0
|
87.5 Percentage of participants
Interval 47.3 to 99.7
|
0 Percentage of participants
NA indicates that upper and lower limit of CI was not estimable as no participant achieved SVR in this group.
|
71.4 Percentage of participants
Interval 41.9 to 91.6
|
96.7 Percentage of participants
Interval 82.8 to 99.9
|
93.3 Percentage of participants
Interval 68.1 to 99.8
|
100 Percentage of participants
Interval 39.8 to 100.0
|
|
Percentage of Participants With Sustained Virologic Response (SVR) at Week 4, 12 and 24 After End of Treatment
24 weeks after end of treatment
|
100 Percentage of participants
Interval 83.2 to 100.0
|
84.0 Percentage of participants
Interval 63.9 to 95.5
|
100 Percentage of participants
Interval 83.2 to 100.0
|
100 Percentage of participants
Interval 83.2 to 100.0
|
87.5 Percentage of participants
Interval 47.3 to 99.7
|
0 Percentage of participants
NA indicates that upper and lower limit of CI was not estimable as no participant achieved SVR in this group.
|
71.4 Percentage of participants
Interval 41.9 to 91.6
|
96.7 Percentage of participants
Interval 82.3 to 99.9
|
93.3 Percentage of participants
Interval 68.1 to 99.8
|
100 Percentage of participants
Interval 39.8 to 100.0
|
SECONDARY outcome
Timeframe: Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)Population: PK set: all safety set participants except those who violated inclusion/exclusion criteria, deviated from protocol, or if data were unavailable/incomplete which influenced PK analysis.
Cmin is the minimum observed plasma concentration of AL-335 and its metabolites (ALS-022399 and ALS-022227). For Pharmacokinetic (PK) analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
Outcome measures
| Measure |
Cohort 1 (8 Weeks Genotype [GT1])
n=11 Participants
Cohort 1 (Participants without Cirrhosis) received single dose of AL-335 400 milligrams (mg) tablets once daily (QD), odalasvir (ODV) 50 mg tablet and simeprevir 100 mg tablet QD for 8 weeks.
|
Cohort 1b + Cohort 4 (8 Weeks GT1)
n=11 Participants
Cohort 1b (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets every other day (QOD) for 8 weeks; Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 8 weeks.
|
Cohort 2 (8 Weeks GT1)
n=16 Participants
Cohort 2 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
|
Cohort 3 (6 Weeks GT1)
n=6 Participants
Cohort 3 (Participants without Cirrhosis) received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD for 6 weeks.
|
Cohort 4 (12 Weeks GT1)
n=27 Participants
Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 12 weeks.
|
Cohort 5a (8 Weeks GT3)
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
|
Cohort 5b (12 Weeks GT3)
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 12 weeks.
|
Cohort 6,7,8 (8 Weeks GT1 F4)
Cohort 6 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks; Cohort 7 and Cohort 8 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 8 weeks.
|
Cohort 9 (12 Weeks GT1 F4)
Cohort 9 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
|
Cohort 11 (12 Weeks GT2 F4)
Cohort 11 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Minimum Observed Plasma Concentration (Cmin) of AL-335 and Its Metabolites (ALS-022399 and ALS-022227)
AL-335
|
0.0 nanogram per milliliter (ng/ml)
Standard Deviation 0.0
|
0.0 nanogram per milliliter (ng/ml)
Standard Deviation 0.0
|
0.0 nanogram per milliliter (ng/ml)
Standard Deviation 0.0
|
0.0 nanogram per milliliter (ng/ml)
Standard Deviation 0.0
|
0.0 nanogram per milliliter (ng/ml)
Standard Deviation 0.0
|
—
|
—
|
—
|
—
|
—
|
|
Minimum Observed Plasma Concentration (Cmin) of AL-335 and Its Metabolites (ALS-022399 and ALS-022227)
ALS-022399
|
0.000 nanogram per milliliter (ng/ml)
Standard Deviation 0.000
|
0.000 nanogram per milliliter (ng/ml)
Standard Deviation 0.000
|
0.308 nanogram per milliliter (ng/ml)
Standard Deviation 1.233
|
0.000 nanogram per milliliter (ng/ml)
Standard Deviation 0.000
|
0.280 nanogram per milliliter (ng/ml)
Standard Deviation 0.814
|
—
|
—
|
—
|
—
|
—
|
|
Minimum Observed Plasma Concentration (Cmin) of AL-335 and Its Metabolites (ALS-022399 and ALS-022227)
ALS-022227
|
35.73 nanogram per milliliter (ng/ml)
Standard Deviation 13.61
|
35.80 nanogram per milliliter (ng/ml)
Standard Deviation 11.15
|
57.25 nanogram per milliliter (ng/ml)
Standard Deviation 31.63
|
68.30 nanogram per milliliter (ng/ml)
Standard Deviation 38.33
|
64.96 nanogram per milliliter (ng/ml)
Standard Deviation 28.63
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)Population: PK set: all safety set participants except those who violated inclusion/exclusion criteria, deviated from protocol, or if data were unavailable/incomplete which influenced PK analysis.
Cmax is the maximum observed plasma concentration of AL-335 and its metabolites (ALS-022227). For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
Outcome measures
| Measure |
Cohort 1 (8 Weeks Genotype [GT1])
n=11 Participants
Cohort 1 (Participants without Cirrhosis) received single dose of AL-335 400 milligrams (mg) tablets once daily (QD), odalasvir (ODV) 50 mg tablet and simeprevir 100 mg tablet QD for 8 weeks.
|
Cohort 1b + Cohort 4 (8 Weeks GT1)
n=11 Participants
Cohort 1b (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets every other day (QOD) for 8 weeks; Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 8 weeks.
|
Cohort 2 (8 Weeks GT1)
n=16 Participants
Cohort 2 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
|
Cohort 3 (6 Weeks GT1)
n=6 Participants
Cohort 3 (Participants without Cirrhosis) received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD for 6 weeks.
|
Cohort 4 (12 Weeks GT1)
n=27 Participants
Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 12 weeks.
|
Cohort 5a (8 Weeks GT3)
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
|
Cohort 5b (12 Weeks GT3)
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 12 weeks.
|
Cohort 6,7,8 (8 Weeks GT1 F4)
Cohort 6 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks; Cohort 7 and Cohort 8 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 8 weeks.
|
Cohort 9 (12 Weeks GT1 F4)
Cohort 9 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
|
Cohort 11 (12 Weeks GT2 F4)
Cohort 11 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of AL-335 and Its Metabolites (ALS-022399 and ALS-022227)
AL-335
|
414.79 ng/mL
Standard Deviation 317.93
|
547.36 ng/mL
Standard Deviation 226.06
|
563.04 ng/mL
Standard Deviation 423.53
|
529.17 ng/mL
Standard Deviation 265.17
|
677.59 ng/mL
Standard Deviation 554.83
|
—
|
—
|
—
|
—
|
—
|
|
Maximum Observed Plasma Concentration (Cmax) of AL-335 and Its Metabolites (ALS-022399 and ALS-022227)
ALS-022399
|
103.57 ng/mL
Standard Deviation 52.25
|
148.89 ng/mL
Standard Deviation 48.77
|
174.89 ng/mL
Standard Deviation 87.05
|
158.80 ng/mL
Standard Deviation 55.97
|
186.28 ng/mL
Standard Deviation 113.18
|
—
|
—
|
—
|
—
|
—
|
|
Maximum Observed Plasma Concentration (Cmax) of AL-335 and Its Metabolites (ALS-022399 and ALS-022227)
ALS-022227
|
364.4 ng/mL
Standard Deviation 129.1
|
392.6 ng/mL
Standard Deviation 144.2
|
658.0 ng/mL
Standard Deviation 275.1
|
643.2 ng/mL
Standard Deviation 318.4
|
619.7 ng/mL
Standard Deviation 224.1
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)Population: PK set: all safety set participants except those who violated inclusion/exclusion criteria, deviated from protocol, or if data were unavailable/incomplete which influenced PK analysis. Here, 'n' signifies the number of participants analyzed for specified analyte.
Ctrough is the trough plasma concentration for AL-335 and its metabolites (ALS-022399 and ALS-022227). For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
Outcome measures
| Measure |
Cohort 1 (8 Weeks Genotype [GT1])
n=11 Participants
Cohort 1 (Participants without Cirrhosis) received single dose of AL-335 400 milligrams (mg) tablets once daily (QD), odalasvir (ODV) 50 mg tablet and simeprevir 100 mg tablet QD for 8 weeks.
|
Cohort 1b + Cohort 4 (8 Weeks GT1)
n=11 Participants
Cohort 1b (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets every other day (QOD) for 8 weeks; Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 8 weeks.
|
Cohort 2 (8 Weeks GT1)
n=16 Participants
Cohort 2 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
|
Cohort 3 (6 Weeks GT1)
n=6 Participants
Cohort 3 (Participants without Cirrhosis) received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD for 6 weeks.
|
Cohort 4 (12 Weeks GT1)
n=27 Participants
Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 12 weeks.
|
Cohort 5a (8 Weeks GT3)
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
|
Cohort 5b (12 Weeks GT3)
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 12 weeks.
|
Cohort 6,7,8 (8 Weeks GT1 F4)
Cohort 6 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks; Cohort 7 and Cohort 8 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 8 weeks.
|
Cohort 9 (12 Weeks GT1 F4)
Cohort 9 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
|
Cohort 11 (12 Weeks GT2 F4)
Cohort 11 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Trough Plasma Concentration (Ctrough) for AL-335 and Its Metabolites (ALS-022399 and ALS-022227)
ALS-022399
|
—
|
—
|
4.640 ng/ml
Standard Deviation 4.018
|
4.570 ng/ml
Standard Deviation 2.899
|
4.400 ng/ml
Standard Deviation 2.560
|
—
|
—
|
—
|
—
|
—
|
|
Trough Plasma Concentration (Ctrough) for AL-335 and Its Metabolites (ALS-022399 and ALS-022227)
ALS-022227
|
42.74 ng/ml
Standard Deviation 19.26
|
36.77 ng/ml
Standard Deviation 10.42
|
61.82 ng/ml
Standard Deviation 35.47
|
86.20 ng/ml
Standard Deviation 56.31
|
73.85 ng/ml
Standard Deviation 35.15
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)Population: PK set: all safety set participants except those who violated inclusion/exclusion criteria, deviated from protocol, or if data were unavailable/incomplete which influenced PK analysis.
Tmax is the time to reach the maximum plasma concentration of AL-335, ALS-022399 and ALS-022227. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
Outcome measures
| Measure |
Cohort 1 (8 Weeks Genotype [GT1])
n=11 Participants
Cohort 1 (Participants without Cirrhosis) received single dose of AL-335 400 milligrams (mg) tablets once daily (QD), odalasvir (ODV) 50 mg tablet and simeprevir 100 mg tablet QD for 8 weeks.
|
Cohort 1b + Cohort 4 (8 Weeks GT1)
n=11 Participants
Cohort 1b (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets every other day (QOD) for 8 weeks; Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 8 weeks.
|
Cohort 2 (8 Weeks GT1)
n=16 Participants
Cohort 2 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
|
Cohort 3 (6 Weeks GT1)
n=6 Participants
Cohort 3 (Participants without Cirrhosis) received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD for 6 weeks.
|
Cohort 4 (12 Weeks GT1)
n=27 Participants
Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 12 weeks.
|
Cohort 5a (8 Weeks GT3)
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
|
Cohort 5b (12 Weeks GT3)
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 12 weeks.
|
Cohort 6,7,8 (8 Weeks GT1 F4)
Cohort 6 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks; Cohort 7 and Cohort 8 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 8 weeks.
|
Cohort 9 (12 Weeks GT1 F4)
Cohort 9 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
|
Cohort 11 (12 Weeks GT2 F4)
Cohort 11 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Time to Reach the Maximum Plasma Concentration (Tmax) of AL-335 and Its Metabolites (ALS-022399 and ALS-022227)
AL-335
|
2.000 Hours
Interval 0.5 to 4.0
|
2.000 Hours
Interval 1.0 to 4.0
|
1.500 Hours
Interval 1.0 to 4.0
|
1.000 Hours
Interval 1.0 to 2.0
|
2.000 Hours
Interval 0.5 to 4.0
|
—
|
—
|
—
|
—
|
—
|
|
Time to Reach the Maximum Plasma Concentration (Tmax) of AL-335 and Its Metabolites (ALS-022399 and ALS-022227)
ALS-022399
|
3.0 Hours
Interval 1.0 to 6.0
|
3.000 Hours
Interval 2.0 to 4.0
|
3.000 Hours
Interval 1.0 to 4.0
|
2.000 Hours
Interval 1.0 to 4.0
|
3.000 Hours
Interval 2.0 to 6.0
|
—
|
—
|
—
|
—
|
—
|
|
Time to Reach the Maximum Plasma Concentration (Tmax) of AL-335 and Its Metabolites (ALS-022399 and ALS-022227)
ALS-022227
|
4.000 Hours
Interval 2.0 to 4.6
|
4.000 Hours
Interval 3.0 to 6.0
|
3.500 Hours
Interval 2.0 to 6.0
|
3.500 Hours
Interval 2.0 to 6.0
|
4.000 Hours
Interval 2.0 to 6.0
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)Population: PK set: all safety set participants except those who violated inclusion/exclusion criteria, deviated from protocol, or if data were unavailable/incomplete which influenced PK analysis.
AUC(0-last) is the area under the plasma concentration-time curve from time 0 to last measurable plasma concentration of AL-335, ALS-022399 and ALS-022227. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
Outcome measures
| Measure |
Cohort 1 (8 Weeks Genotype [GT1])
n=11 Participants
Cohort 1 (Participants without Cirrhosis) received single dose of AL-335 400 milligrams (mg) tablets once daily (QD), odalasvir (ODV) 50 mg tablet and simeprevir 100 mg tablet QD for 8 weeks.
|
Cohort 1b + Cohort 4 (8 Weeks GT1)
n=11 Participants
Cohort 1b (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets every other day (QOD) for 8 weeks; Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 8 weeks.
|
Cohort 2 (8 Weeks GT1)
n=16 Participants
Cohort 2 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
|
Cohort 3 (6 Weeks GT1)
n=6 Participants
Cohort 3 (Participants without Cirrhosis) received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD for 6 weeks.
|
Cohort 4 (12 Weeks GT1)
n=27 Participants
Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 12 weeks.
|
Cohort 5a (8 Weeks GT3)
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
|
Cohort 5b (12 Weeks GT3)
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 12 weeks.
|
Cohort 6,7,8 (8 Weeks GT1 F4)
Cohort 6 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks; Cohort 7 and Cohort 8 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 8 weeks.
|
Cohort 9 (12 Weeks GT1 F4)
Cohort 9 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
|
Cohort 11 (12 Weeks GT2 F4)
Cohort 11 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Plasma Concentration-Time Curve From Time 0 to Last Measurable Plasma Concentration (AUC [0-last]) of AL-335 and Its Metabolites (ALS-022399 and ALS-022227)
AL-335
|
1049.3 nanogram*hours per milliliters (ng*h/mL)
Standard Deviation 890.0
|
1185.8 nanogram*hours per milliliters (ng*h/mL)
Standard Deviation 502.8
|
1526.3 nanogram*hours per milliliters (ng*h/mL)
Standard Deviation 1328.9
|
1178.5 nanogram*hours per milliliters (ng*h/mL)
Standard Deviation 594.0
|
1774.8 nanogram*hours per milliliters (ng*h/mL)
Standard Deviation 1348.5
|
—
|
—
|
—
|
—
|
—
|
|
Area Under the Plasma Concentration-Time Curve From Time 0 to Last Measurable Plasma Concentration (AUC [0-last]) of AL-335 and Its Metabolites (ALS-022399 and ALS-022227)
ALS-022399
|
469.3 nanogram*hours per milliliters (ng*h/mL)
Standard Deviation 224.0
|
660.7 nanogram*hours per milliliters (ng*h/mL)
Standard Deviation 211.5
|
945.2 nanogram*hours per milliliters (ng*h/mL)
Standard Deviation 551.1
|
844.2 nanogram*hours per milliliters (ng*h/mL)
Standard Deviation 287.9
|
933.3 nanogram*hours per milliliters (ng*h/mL)
Standard Deviation 544.3
|
—
|
—
|
—
|
—
|
—
|
|
Area Under the Plasma Concentration-Time Curve From Time 0 to Last Measurable Plasma Concentration (AUC [0-last]) of AL-335 and Its Metabolites (ALS-022399 and ALS-022227)
ALS-022227
|
2920.0 nanogram*hours per milliliters (ng*h/mL)
Standard Deviation 1029.1
|
3238.2 nanogram*hours per milliliters (ng*h/mL)
Standard Deviation 972.8
|
5258.1 nanogram*hours per milliliters (ng*h/mL)
Standard Deviation 1969.4
|
5218.3 nanogram*hours per milliliters (ng*h/mL)
Standard Deviation 2011.9
|
5425.2 nanogram*hours per milliliters (ng*h/mL)
Standard Deviation 1878.2
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdosePopulation: PK set: all safety set participants except those who violated inclusion/exclusion criteria, deviated from protocol, or if data were unavailable/incomplete which influenced PK analysis.
AUC(0-24) is the area under the plasma concentration-time curve from time zero to time 24 hours for AL-335, ALS-022399 and ALS-022227. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
Outcome measures
| Measure |
Cohort 1 (8 Weeks Genotype [GT1])
n=11 Participants
Cohort 1 (Participants without Cirrhosis) received single dose of AL-335 400 milligrams (mg) tablets once daily (QD), odalasvir (ODV) 50 mg tablet and simeprevir 100 mg tablet QD for 8 weeks.
|
Cohort 1b + Cohort 4 (8 Weeks GT1)
n=11 Participants
Cohort 1b (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets every other day (QOD) for 8 weeks; Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 8 weeks.
|
Cohort 2 (8 Weeks GT1)
n=16 Participants
Cohort 2 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
|
Cohort 3 (6 Weeks GT1)
n=6 Participants
Cohort 3 (Participants without Cirrhosis) received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD for 6 weeks.
|
Cohort 4 (12 Weeks GT1)
n=27 Participants
Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 12 weeks.
|
Cohort 5a (8 Weeks GT3)
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
|
Cohort 5b (12 Weeks GT3)
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 12 weeks.
|
Cohort 6,7,8 (8 Weeks GT1 F4)
Cohort 6 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks; Cohort 7 and Cohort 8 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 8 weeks.
|
Cohort 9 (12 Weeks GT1 F4)
Cohort 9 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
|
Cohort 11 (12 Weeks GT2 F4)
Cohort 11 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Plasma Concentration Time-Curve at 24 Hours (AUC0-24) for AL-335 and Its Metabolites (ALS-022399 and ALS-022227)
AL-335
|
1058.0 ng*h/mL
Standard Deviation 886.9
|
1197.2 ng*h/mL
Standard Deviation 507.7
|
1532.7 ng*h/mL
Standard Deviation 1329.5
|
1187.3 ng*h/mL
Standard Deviation 600.9
|
1792.2 ng*h/mL
Standard Deviation 1350.9
|
—
|
—
|
—
|
—
|
—
|
|
Area Under the Plasma Concentration Time-Curve at 24 Hours (AUC0-24) for AL-335 and Its Metabolites (ALS-022399 and ALS-022227)
ALS-022399
|
500.5 ng*h/mL
Standard Deviation 230.8
|
718.0 ng*h/mL
Standard Deviation 240.7
|
1009.7 ng*h/mL
Standard Deviation 599.4
|
932.7 ng*h/mL
Standard Deviation 330.1
|
1044.7 ng*h/mL
Standard Deviation 561.1
|
—
|
—
|
—
|
—
|
—
|
|
Area Under the Plasma Concentration Time-Curve at 24 Hours (AUC0-24) for AL-335 and Its Metabolites (ALS-022399 and ALS-022227)
ALS-022227
|
2897.0 ng*h/mL
Standard Deviation 1081.8
|
3238.2 ng*h/mL
Standard Deviation 972.8
|
5258.1 ng*h/mL
Standard Deviation 1969.4
|
4806.0 ng*h/mL
Standard Deviation 1945.4
|
5425.2 ng*h/mL
Standard Deviation 1878.2
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)Population: PK set: all safety set participants except those who violated inclusion/exclusion criteria, deviated from protocol, or if data were unavailable/incomplete which influenced PK analysis.
Clast is the last measurable plasma concentration (Clast) of AL-335, ALS-022399 and ALS-022227. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
Outcome measures
| Measure |
Cohort 1 (8 Weeks Genotype [GT1])
n=11 Participants
Cohort 1 (Participants without Cirrhosis) received single dose of AL-335 400 milligrams (mg) tablets once daily (QD), odalasvir (ODV) 50 mg tablet and simeprevir 100 mg tablet QD for 8 weeks.
|
Cohort 1b + Cohort 4 (8 Weeks GT1)
n=11 Participants
Cohort 1b (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets every other day (QOD) for 8 weeks; Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 8 weeks.
|
Cohort 2 (8 Weeks GT1)
n=16 Participants
Cohort 2 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
|
Cohort 3 (6 Weeks GT1)
n=6 Participants
Cohort 3 (Participants without Cirrhosis) received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD for 6 weeks.
|
Cohort 4 (12 Weeks GT1)
n=27 Participants
Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 12 weeks.
|
Cohort 5a (8 Weeks GT3)
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
|
Cohort 5b (12 Weeks GT3)
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 12 weeks.
|
Cohort 6,7,8 (8 Weeks GT1 F4)
Cohort 6 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks; Cohort 7 and Cohort 8 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 8 weeks.
|
Cohort 9 (12 Weeks GT1 F4)
Cohort 9 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
|
Cohort 11 (12 Weeks GT2 F4)
Cohort 11 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Last Measurable Plasma Concentration (Clast) of AL-335 and Its Metabolite (ALS-022399 and ALS-022227)
AL-335
|
5.931 ng/ml
Standard Deviation 4.752
|
7.077 ng/ml
Standard Deviation 4.676
|
4.983 ng/ml
Standard Deviation 3.339
|
5.698 ng/ml
Standard Deviation 5.620
|
5.811 ng/ml
Standard Deviation 8.622
|
—
|
—
|
—
|
—
|
—
|
|
Last Measurable Plasma Concentration (Clast) of AL-335 and Its Metabolite (ALS-022399 and ALS-022227)
ALS-022399
|
5.995 ng/ml
Standard Deviation 1.649
|
10.335 ng/ml
Standard Deviation 5.558
|
14.591 ng/ml
Standard Deviation 10.741
|
14.793 ng/ml
Standard Deviation 8.738
|
17.520 ng/ml
Standard Deviation 10.972
|
—
|
—
|
—
|
—
|
—
|
|
Last Measurable Plasma Concentration (Clast) of AL-335 and Its Metabolite (ALS-022399 and ALS-022227)
ALS-022227
|
38.28 ng/ml
Standard Deviation 12.20
|
47.26 ng/ml
Standard Deviation 10.68
|
67.08 ng/ml
Standard Deviation 40.66
|
69.18 ng/ml
Standard Deviation 38.01
|
72.14 ng/ml
Standard Deviation 29.23
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)Population: PK set: all safety set participants except those who violated inclusion/exclusion criteria, deviated from protocol, or if data were unavailable/incomplete which influenced PK analysis.
Tlast is the time corresponding to last measurable plasma concentration for AL-335, ALS-022399 and ALS-022227. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
Outcome measures
| Measure |
Cohort 1 (8 Weeks Genotype [GT1])
n=11 Participants
Cohort 1 (Participants without Cirrhosis) received single dose of AL-335 400 milligrams (mg) tablets once daily (QD), odalasvir (ODV) 50 mg tablet and simeprevir 100 mg tablet QD for 8 weeks.
|
Cohort 1b + Cohort 4 (8 Weeks GT1)
n=11 Participants
Cohort 1b (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets every other day (QOD) for 8 weeks; Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 8 weeks.
|
Cohort 2 (8 Weeks GT1)
n=16 Participants
Cohort 2 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
|
Cohort 3 (6 Weeks GT1)
n=6 Participants
Cohort 3 (Participants without Cirrhosis) received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD for 6 weeks.
|
Cohort 4 (12 Weeks GT1)
n=27 Participants
Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 12 weeks.
|
Cohort 5a (8 Weeks GT3)
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
|
Cohort 5b (12 Weeks GT3)
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 12 weeks.
|
Cohort 6,7,8 (8 Weeks GT1 F4)
Cohort 6 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks; Cohort 7 and Cohort 8 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 8 weeks.
|
Cohort 9 (12 Weeks GT1 F4)
Cohort 9 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
|
Cohort 11 (12 Weeks GT2 F4)
Cohort 11 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Time Corresponding to Last Measurable Plasma Concentration (Tlast) for AL-335 and Its Metabolites (ALS-022399 and ALS-022227)
AL-335
|
6.000 Hours
Interval 6.0 to 9.0
|
6.000 Hours
Interval 6.0 to 9.0
|
6.000 Hours
Interval 4.0 to 24.1
|
6.025 Hours
Interval 6.0 to 9.0
|
8.670 Hours
Interval 5.98 to 12.0
|
—
|
—
|
—
|
—
|
—
|
|
Time Corresponding to Last Measurable Plasma Concentration (Tlast) for AL-335 and Its Metabolites (ALS-022399 and ALS-022227)
ALS-022399
|
12.000 Hours
Interval 9.0 to 12.0
|
12.000 Hours
Interval 12.0 to 12.0
|
12.000 Hours
Interval 9.0 to 24.1
|
12.000 Hours
Interval 12.0 to 12.0
|
12.000 Hours
Interval 8.5 to 24.0
|
—
|
—
|
—
|
—
|
—
|
|
Time Corresponding to Last Measurable Plasma Concentration (Tlast) for AL-335 and Its Metabolites (ALS-022399 and ALS-022227)
ALS-022227
|
24.00 Hours
Interval 24.0 to 24.1
|
24.00 Hours
Interval 23.7 to 24.1
|
24.00 Hours
Interval 24.0 to 24.1
|
24.00 Hours
Interval 24.0 to 24.2
|
23.90 Hours
Interval 23.5 to 24.0
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)Population: PK set: all safety set participants except those who violated inclusion/exclusion criteria, deviated from protocol, or if data were unavailable/incomplete which influenced PK analysis.
Css,avg is the average plasma concentration at steady state of ALS-022227. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
Outcome measures
| Measure |
Cohort 1 (8 Weeks Genotype [GT1])
n=11 Participants
Cohort 1 (Participants without Cirrhosis) received single dose of AL-335 400 milligrams (mg) tablets once daily (QD), odalasvir (ODV) 50 mg tablet and simeprevir 100 mg tablet QD for 8 weeks.
|
Cohort 1b + Cohort 4 (8 Weeks GT1)
n=11 Participants
Cohort 1b (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets every other day (QOD) for 8 weeks; Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 8 weeks.
|
Cohort 2 (8 Weeks GT1)
n=16 Participants
Cohort 2 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
|
Cohort 3 (6 Weeks GT1)
n=6 Participants
Cohort 3 (Participants without Cirrhosis) received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD for 6 weeks.
|
Cohort 4 (12 Weeks GT1)
n=27 Participants
Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 12 weeks.
|
Cohort 5a (8 Weeks GT3)
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
|
Cohort 5b (12 Weeks GT3)
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 12 weeks.
|
Cohort 6,7,8 (8 Weeks GT1 F4)
Cohort 6 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks; Cohort 7 and Cohort 8 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 8 weeks.
|
Cohort 9 (12 Weeks GT1 F4)
Cohort 9 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
|
Cohort 11 (12 Weeks GT2 F4)
Cohort 11 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Average Plasma Concentration at Steady State (Css,Avg) of ALS-022227
|
121.49 ng/ml
Standard Deviation 42.81
|
135.20 ng/ml
Standard Deviation 41.16
|
218.88 ng/ml
Standard Deviation 81.80
|
217.17 ng/ml
Standard Deviation 83.26
|
227.37 ng/ml
Standard Deviation 78.46
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)Population: PK set: all safety set participants except those who violated inclusion/exclusion criteria, deviated from protocol, or if data were unavailable/incomplete which influenced PK analysis.
Cmin is the minimum measured plasma concentration of simeprevir. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
Outcome measures
| Measure |
Cohort 1 (8 Weeks Genotype [GT1])
n=11 Participants
Cohort 1 (Participants without Cirrhosis) received single dose of AL-335 400 milligrams (mg) tablets once daily (QD), odalasvir (ODV) 50 mg tablet and simeprevir 100 mg tablet QD for 8 weeks.
|
Cohort 1b + Cohort 4 (8 Weeks GT1)
n=16 Participants
Cohort 1b (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets every other day (QOD) for 8 weeks; Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 8 weeks.
|
Cohort 2 (8 Weeks GT1)
n=6 Participants
Cohort 2 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
|
Cohort 3 (6 Weeks GT1)
n=27 Participants
Cohort 3 (Participants without Cirrhosis) received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD for 6 weeks.
|
Cohort 4 (12 Weeks GT1)
Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 12 weeks.
|
Cohort 5a (8 Weeks GT3)
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
|
Cohort 5b (12 Weeks GT3)
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 12 weeks.
|
Cohort 6,7,8 (8 Weeks GT1 F4)
Cohort 6 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks; Cohort 7 and Cohort 8 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 8 weeks.
|
Cohort 9 (12 Weeks GT1 F4)
Cohort 9 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
|
Cohort 11 (12 Weeks GT2 F4)
Cohort 11 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Cmin of Simeprevir
|
379.75 ng/ml
Standard Deviation 247.02
|
452.65 ng/ml
Standard Deviation 641.99
|
517.00 ng/ml
Standard Deviation 416.45
|
561.19 ng/ml
Standard Deviation 424.71
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)Population: PK set: all safety set participants except those who violated inclusion/exclusion criteria, deviated from protocol, or if data were unavailable/incomplete which influenced PK analysis.
Cmax is the maximum measured plasma concentration of simeprevir. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
Outcome measures
| Measure |
Cohort 1 (8 Weeks Genotype [GT1])
n=11 Participants
Cohort 1 (Participants without Cirrhosis) received single dose of AL-335 400 milligrams (mg) tablets once daily (QD), odalasvir (ODV) 50 mg tablet and simeprevir 100 mg tablet QD for 8 weeks.
|
Cohort 1b + Cohort 4 (8 Weeks GT1)
n=16 Participants
Cohort 1b (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets every other day (QOD) for 8 weeks; Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 8 weeks.
|
Cohort 2 (8 Weeks GT1)
n=6 Participants
Cohort 2 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
|
Cohort 3 (6 Weeks GT1)
n=27 Participants
Cohort 3 (Participants without Cirrhosis) received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD for 6 weeks.
|
Cohort 4 (12 Weeks GT1)
Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 12 weeks.
|
Cohort 5a (8 Weeks GT3)
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
|
Cohort 5b (12 Weeks GT3)
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 12 weeks.
|
Cohort 6,7,8 (8 Weeks GT1 F4)
Cohort 6 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks; Cohort 7 and Cohort 8 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 8 weeks.
|
Cohort 9 (12 Weeks GT1 F4)
Cohort 9 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
|
Cohort 11 (12 Weeks GT2 F4)
Cohort 11 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Cmax of Simeprevir
|
1927.7 ng/ml
Standard Deviation 1205.3
|
1537.6 ng/ml
Standard Deviation 1325.2
|
1769.3 ng/ml
Standard Deviation 881.6
|
1925.1 ng/ml
Standard Deviation 1034.0
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)Population: PK set: all safety set participants except those who violated inclusion/exclusion criteria, deviated from protocol, or if data were unavailable/incomplete which influenced PK analysis.
Ctrough is the trough plasma concentration of Simeprevir. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
Outcome measures
| Measure |
Cohort 1 (8 Weeks Genotype [GT1])
n=11 Participants
Cohort 1 (Participants without Cirrhosis) received single dose of AL-335 400 milligrams (mg) tablets once daily (QD), odalasvir (ODV) 50 mg tablet and simeprevir 100 mg tablet QD for 8 weeks.
|
Cohort 1b + Cohort 4 (8 Weeks GT1)
n=16 Participants
Cohort 1b (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets every other day (QOD) for 8 weeks; Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 8 weeks.
|
Cohort 2 (8 Weeks GT1)
n=6 Participants
Cohort 2 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
|
Cohort 3 (6 Weeks GT1)
n=27 Participants
Cohort 3 (Participants without Cirrhosis) received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD for 6 weeks.
|
Cohort 4 (12 Weeks GT1)
Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 12 weeks.
|
Cohort 5a (8 Weeks GT3)
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
|
Cohort 5b (12 Weeks GT3)
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 12 weeks.
|
Cohort 6,7,8 (8 Weeks GT1 F4)
Cohort 6 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks; Cohort 7 and Cohort 8 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 8 weeks.
|
Cohort 9 (12 Weeks GT1 F4)
Cohort 9 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
|
Cohort 11 (12 Weeks GT2 F4)
Cohort 11 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Ctrough of Simeprevir
|
475.42 ng/ml
Standard Deviation 317.63
|
570.64 ng/ml
Standard Deviation 816.36
|
669.00 ng/ml
Standard Deviation 442.50
|
636.88 ng/ml
Standard Deviation 455.94
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)Population: PK set: all safety set participants except those who violated inclusion/exclusion criteria, deviated from protocol, or if data were unavailable/incomplete which influenced PK analysis.
Tmax is the Time to reach the maximum plasma concentration of simeprevir. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
Outcome measures
| Measure |
Cohort 1 (8 Weeks Genotype [GT1])
n=11 Participants
Cohort 1 (Participants without Cirrhosis) received single dose of AL-335 400 milligrams (mg) tablets once daily (QD), odalasvir (ODV) 50 mg tablet and simeprevir 100 mg tablet QD for 8 weeks.
|
Cohort 1b + Cohort 4 (8 Weeks GT1)
n=16 Participants
Cohort 1b (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets every other day (QOD) for 8 weeks; Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 8 weeks.
|
Cohort 2 (8 Weeks GT1)
n=6 Participants
Cohort 2 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
|
Cohort 3 (6 Weeks GT1)
n=27 Participants
Cohort 3 (Participants without Cirrhosis) received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD for 6 weeks.
|
Cohort 4 (12 Weeks GT1)
Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 12 weeks.
|
Cohort 5a (8 Weeks GT3)
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
|
Cohort 5b (12 Weeks GT3)
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 12 weeks.
|
Cohort 6,7,8 (8 Weeks GT1 F4)
Cohort 6 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks; Cohort 7 and Cohort 8 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 8 weeks.
|
Cohort 9 (12 Weeks GT1 F4)
Cohort 9 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
|
Cohort 11 (12 Weeks GT2 F4)
Cohort 11 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Tmax of Simeprevir
|
6.000 Hours
Interval 4.0 to 12.0
|
6.000 Hours
Interval 4.0 to 9.0
|
6.000 Hours
Interval 4.0 to 6.05
|
6.000 Hours
Interval 3.0 to 8.5
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)Population: PK set: all safety set participants except those who violated inclusion/exclusion criteria, deviated from protocol, or if data were unavailable/incomplete which influenced PK analysis.
AUC (0-last) is the area under the plasma concentration-time curve from time 0 to last measurable plasma concentration of simeprevir. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
Outcome measures
| Measure |
Cohort 1 (8 Weeks Genotype [GT1])
n=11 Participants
Cohort 1 (Participants without Cirrhosis) received single dose of AL-335 400 milligrams (mg) tablets once daily (QD), odalasvir (ODV) 50 mg tablet and simeprevir 100 mg tablet QD for 8 weeks.
|
Cohort 1b + Cohort 4 (8 Weeks GT1)
n=16 Participants
Cohort 1b (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets every other day (QOD) for 8 weeks; Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 8 weeks.
|
Cohort 2 (8 Weeks GT1)
n=6 Participants
Cohort 2 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
|
Cohort 3 (6 Weeks GT1)
n=27 Participants
Cohort 3 (Participants without Cirrhosis) received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD for 6 weeks.
|
Cohort 4 (12 Weeks GT1)
Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 12 weeks.
|
Cohort 5a (8 Weeks GT3)
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
|
Cohort 5b (12 Weeks GT3)
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 12 weeks.
|
Cohort 6,7,8 (8 Weeks GT1 F4)
Cohort 6 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks; Cohort 7 and Cohort 8 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 8 weeks.
|
Cohort 9 (12 Weeks GT1 F4)
Cohort 9 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
|
Cohort 11 (12 Weeks GT2 F4)
Cohort 11 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
AUC (0-last) of Simeprevir
|
25018.2 ng*h/ml
Standard Deviation 15248.7
|
23061.3 ng*h/ml
Standard Deviation 24724.4
|
25266.7 ng*h/ml
Standard Deviation 15523.4
|
27070.7 ng*h/ml
Standard Deviation 15895.7
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdosePopulation: PK set: all safety set participants except those who violated inclusion/exclusion criteria, deviated from protocol, or if data were unavailable/incomplete which influenced PK analysis.
AUC (0-24) is the area under the plasma concentration-time curve from time 0 to 24 hours of simeprevir. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
Outcome measures
| Measure |
Cohort 1 (8 Weeks Genotype [GT1])
n=11 Participants
Cohort 1 (Participants without Cirrhosis) received single dose of AL-335 400 milligrams (mg) tablets once daily (QD), odalasvir (ODV) 50 mg tablet and simeprevir 100 mg tablet QD for 8 weeks.
|
Cohort 1b + Cohort 4 (8 Weeks GT1)
n=16 Participants
Cohort 1b (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets every other day (QOD) for 8 weeks; Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 8 weeks.
|
Cohort 2 (8 Weeks GT1)
n=6 Participants
Cohort 2 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
|
Cohort 3 (6 Weeks GT1)
n=27 Participants
Cohort 3 (Participants without Cirrhosis) received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD for 6 weeks.
|
Cohort 4 (12 Weeks GT1)
Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 12 weeks.
|
Cohort 5a (8 Weeks GT3)
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
|
Cohort 5b (12 Weeks GT3)
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 12 weeks.
|
Cohort 6,7,8 (8 Weeks GT1 F4)
Cohort 6 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks; Cohort 7 and Cohort 8 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 8 weeks.
|
Cohort 9 (12 Weeks GT1 F4)
Cohort 9 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
|
Cohort 11 (12 Weeks GT2 F4)
Cohort 11 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
AUC (0-24) of Simeprevir
|
25018.2 ng*h/ml
Standard Deviation 15248.7
|
23061.3 ng*h/ml
Standard Deviation 24724.4
|
25266.7 ng*h/ml
Standard Deviation 15523.4
|
27070.7 ng*h/ml
Standard Deviation 15895.7
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)Population: PK set: all safety set participants except those who violated inclusion/exclusion criteria, deviated from protocol, or if data were unavailable/incomplete which influenced PK analysis.
Clast is the maximum measured plasma concentration of simeprevir. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
Outcome measures
| Measure |
Cohort 1 (8 Weeks Genotype [GT1])
n=11 Participants
Cohort 1 (Participants without Cirrhosis) received single dose of AL-335 400 milligrams (mg) tablets once daily (QD), odalasvir (ODV) 50 mg tablet and simeprevir 100 mg tablet QD for 8 weeks.
|
Cohort 1b + Cohort 4 (8 Weeks GT1)
n=16 Participants
Cohort 1b (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets every other day (QOD) for 8 weeks; Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 8 weeks.
|
Cohort 2 (8 Weeks GT1)
n=6 Participants
Cohort 2 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
|
Cohort 3 (6 Weeks GT1)
n=27 Participants
Cohort 3 (Participants without Cirrhosis) received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD for 6 weeks.
|
Cohort 4 (12 Weeks GT1)
Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 12 weeks.
|
Cohort 5a (8 Weeks GT3)
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
|
Cohort 5b (12 Weeks GT3)
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 12 weeks.
|
Cohort 6,7,8 (8 Weeks GT1 F4)
Cohort 6 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks; Cohort 7 and Cohort 8 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 8 weeks.
|
Cohort 9 (12 Weeks GT1 F4)
Cohort 9 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
|
Cohort 11 (12 Weeks GT2 F4)
Cohort 11 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Clast of Simeprevir
|
402.55 ng/ml
Standard Deviation 244.20
|
481.76 ng/ml
Standard Deviation 644.76
|
538.67 ng/ml
Standard Deviation 456.21
|
602.60 ng/ml
Standard Deviation 453.12
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)Population: PK set: all safety set participants except those who violated inclusion/exclusion criteria, deviated from protocol, or if data were unavailable/incomplete which influenced PK analysis.
Tlast is the time corresponding to last measurable plasma concentration of simeprevir. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
Outcome measures
| Measure |
Cohort 1 (8 Weeks Genotype [GT1])
n=11 Participants
Cohort 1 (Participants without Cirrhosis) received single dose of AL-335 400 milligrams (mg) tablets once daily (QD), odalasvir (ODV) 50 mg tablet and simeprevir 100 mg tablet QD for 8 weeks.
|
Cohort 1b + Cohort 4 (8 Weeks GT1)
n=16 Participants
Cohort 1b (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets every other day (QOD) for 8 weeks; Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 8 weeks.
|
Cohort 2 (8 Weeks GT1)
n=6 Participants
Cohort 2 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
|
Cohort 3 (6 Weeks GT1)
n=27 Participants
Cohort 3 (Participants without Cirrhosis) received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD for 6 weeks.
|
Cohort 4 (12 Weeks GT1)
Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 12 weeks.
|
Cohort 5a (8 Weeks GT3)
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
|
Cohort 5b (12 Weeks GT3)
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 12 weeks.
|
Cohort 6,7,8 (8 Weeks GT1 F4)
Cohort 6 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks; Cohort 7 and Cohort 8 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 8 weeks.
|
Cohort 9 (12 Weeks GT1 F4)
Cohort 9 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
|
Cohort 11 (12 Weeks GT2 F4)
Cohort 11 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Tlast of Simeprevir
|
24.00 Hours
Interval 24.0 to 24.1
|
24.00 Hours
Interval 24.0 to 24.1
|
24.00 Hours
Interval 24.0 to 24.2
|
23.90 Hours
Interval 23.5 to 24.0
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)Population: PK set: all safety set participants except those who violated inclusion/exclusion criteria, deviated from protocol, or if data were unavailable/incomplete which influenced PK analysis.
Css,avg is the average plasma concentration at steady state of simeprevir. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
Outcome measures
| Measure |
Cohort 1 (8 Weeks Genotype [GT1])
n=11 Participants
Cohort 1 (Participants without Cirrhosis) received single dose of AL-335 400 milligrams (mg) tablets once daily (QD), odalasvir (ODV) 50 mg tablet and simeprevir 100 mg tablet QD for 8 weeks.
|
Cohort 1b + Cohort 4 (8 Weeks GT1)
n=16 Participants
Cohort 1b (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets every other day (QOD) for 8 weeks; Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 8 weeks.
|
Cohort 2 (8 Weeks GT1)
n=6 Participants
Cohort 2 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
|
Cohort 3 (6 Weeks GT1)
n=27 Participants
Cohort 3 (Participants without Cirrhosis) received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD for 6 weeks.
|
Cohort 4 (12 Weeks GT1)
Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 12 weeks.
|
Cohort 5a (8 Weeks GT3)
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
|
Cohort 5b (12 Weeks GT3)
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 12 weeks.
|
Cohort 6,7,8 (8 Weeks GT1 F4)
Cohort 6 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks; Cohort 7 and Cohort 8 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 8 weeks.
|
Cohort 9 (12 Weeks GT1 F4)
Cohort 9 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
|
Cohort 11 (12 Weeks GT2 F4)
Cohort 11 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Average Plasma Concentration at Steady State (Css,Avg) of Simeprevir
|
1042.8 ng/ml
Standard Deviation 634.3
|
960.5 ng/ml
Standard Deviation 1030.7
|
1053.8 ng/ml
Standard Deviation 647.8
|
1134.6 ng/ml
Standard Deviation 666.6
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)Population: PK set: all safety set participants except those who violated inclusion/exclusion criteria, deviated from protocol, or if data were unavailable/incomplete which influenced PK analysis.
Cmin is the minimum observed plasma concentration of odalasvir. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
Outcome measures
| Measure |
Cohort 1 (8 Weeks Genotype [GT1])
n=11 Participants
Cohort 1 (Participants without Cirrhosis) received single dose of AL-335 400 milligrams (mg) tablets once daily (QD), odalasvir (ODV) 50 mg tablet and simeprevir 100 mg tablet QD for 8 weeks.
|
Cohort 1b + Cohort 4 (8 Weeks GT1)
n=11 Participants
Cohort 1b (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets every other day (QOD) for 8 weeks; Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 8 weeks.
|
Cohort 2 (8 Weeks GT1)
n=16 Participants
Cohort 2 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
|
Cohort 3 (6 Weeks GT1)
n=6 Participants
Cohort 3 (Participants without Cirrhosis) received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD for 6 weeks.
|
Cohort 4 (12 Weeks GT1)
n=27 Participants
Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 12 weeks.
|
Cohort 5a (8 Weeks GT3)
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
|
Cohort 5b (12 Weeks GT3)
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 12 weeks.
|
Cohort 6,7,8 (8 Weeks GT1 F4)
Cohort 6 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks; Cohort 7 and Cohort 8 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 8 weeks.
|
Cohort 9 (12 Weeks GT1 F4)
Cohort 9 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
|
Cohort 11 (12 Weeks GT2 F4)
Cohort 11 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Cmin of Odalasvir
|
322.45 ng/ml
Standard Deviation 139.21
|
97.21 ng/ml
Standard Deviation 58.62
|
107.90 ng/ml
Standard Deviation 49.46
|
102.73 ng/ml
Standard Deviation 47.08
|
131.31 ng/ml
Standard Deviation 62.31
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)Population: PK set: all safety set participants except those who violated inclusion/exclusion criteria, deviated from protocol, or if data were unavailable/incomplete which influenced PK analysis.
Cmax is the maximum observed plasma concentration of odalasvir. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
Outcome measures
| Measure |
Cohort 1 (8 Weeks Genotype [GT1])
n=11 Participants
Cohort 1 (Participants without Cirrhosis) received single dose of AL-335 400 milligrams (mg) tablets once daily (QD), odalasvir (ODV) 50 mg tablet and simeprevir 100 mg tablet QD for 8 weeks.
|
Cohort 1b + Cohort 4 (8 Weeks GT1)
n=11 Participants
Cohort 1b (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets every other day (QOD) for 8 weeks; Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 8 weeks.
|
Cohort 2 (8 Weeks GT1)
n=16 Participants
Cohort 2 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
|
Cohort 3 (6 Weeks GT1)
n=6 Participants
Cohort 3 (Participants without Cirrhosis) received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD for 6 weeks.
|
Cohort 4 (12 Weeks GT1)
n=27 Participants
Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 12 weeks.
|
Cohort 5a (8 Weeks GT3)
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
|
Cohort 5b (12 Weeks GT3)
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 12 weeks.
|
Cohort 6,7,8 (8 Weeks GT1 F4)
Cohort 6 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks; Cohort 7 and Cohort 8 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 8 weeks.
|
Cohort 9 (12 Weeks GT1 F4)
Cohort 9 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
|
Cohort 11 (12 Weeks GT2 F4)
Cohort 11 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Cmax of Odalasvir
|
634.27 ng/ml
Standard Deviation 257.29
|
363.36 ng/ml
Standard Deviation 184.48
|
322.46 ng/ml
Standard Deviation 167.29
|
232.85 ng/ml
Standard Deviation 187.53
|
298.67 ng/ml
Standard Deviation 133.99
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)Population: PK set: all safety set participants except those who violated inclusion/exclusion criteria, deviated from protocol, or if data were unavailable/incomplete which influenced PK analysis.
Ctrough is the trough plasma concentration of odalasvir. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
Outcome measures
| Measure |
Cohort 1 (8 Weeks Genotype [GT1])
n=11 Participants
Cohort 1 (Participants without Cirrhosis) received single dose of AL-335 400 milligrams (mg) tablets once daily (QD), odalasvir (ODV) 50 mg tablet and simeprevir 100 mg tablet QD for 8 weeks.
|
Cohort 1b + Cohort 4 (8 Weeks GT1)
n=11 Participants
Cohort 1b (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets every other day (QOD) for 8 weeks; Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 8 weeks.
|
Cohort 2 (8 Weeks GT1)
n=16 Participants
Cohort 2 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
|
Cohort 3 (6 Weeks GT1)
n=6 Participants
Cohort 3 (Participants without Cirrhosis) received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD for 6 weeks.
|
Cohort 4 (12 Weeks GT1)
n=27 Participants
Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 12 weeks.
|
Cohort 5a (8 Weeks GT3)
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
|
Cohort 5b (12 Weeks GT3)
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 12 weeks.
|
Cohort 6,7,8 (8 Weeks GT1 F4)
Cohort 6 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks; Cohort 7 and Cohort 8 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 8 weeks.
|
Cohort 9 (12 Weeks GT1 F4)
Cohort 9 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
|
Cohort 11 (12 Weeks GT2 F4)
Cohort 11 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Ctrough of Odalasvir
|
335.18 ng/ml
Standard Deviation 146.14
|
100.98 ng/ml
Standard Deviation 61.90
|
112.44 ng/ml
Standard Deviation 51.53
|
119.82 ng/ml
Standard Deviation 58.87
|
141.56 ng/ml
Standard Deviation 64.81
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)Population: PK set: all safety set participants except those who violated inclusion/exclusion criteria, deviated from protocol, or if data were unavailable/incomplete which influenced PK analysis.
Tmax is the time to reach the maximum plasma concentration of odalasvir. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
Outcome measures
| Measure |
Cohort 1 (8 Weeks Genotype [GT1])
n=11 Participants
Cohort 1 (Participants without Cirrhosis) received single dose of AL-335 400 milligrams (mg) tablets once daily (QD), odalasvir (ODV) 50 mg tablet and simeprevir 100 mg tablet QD for 8 weeks.
|
Cohort 1b + Cohort 4 (8 Weeks GT1)
n=11 Participants
Cohort 1b (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets every other day (QOD) for 8 weeks; Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 8 weeks.
|
Cohort 2 (8 Weeks GT1)
n=16 Participants
Cohort 2 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
|
Cohort 3 (6 Weeks GT1)
n=6 Participants
Cohort 3 (Participants without Cirrhosis) received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD for 6 weeks.
|
Cohort 4 (12 Weeks GT1)
n=27 Participants
Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 12 weeks.
|
Cohort 5a (8 Weeks GT3)
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
|
Cohort 5b (12 Weeks GT3)
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 12 weeks.
|
Cohort 6,7,8 (8 Weeks GT1 F4)
Cohort 6 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks; Cohort 7 and Cohort 8 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 8 weeks.
|
Cohort 9 (12 Weeks GT1 F4)
Cohort 9 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
|
Cohort 11 (12 Weeks GT2 F4)
Cohort 11 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Tmax of Odalasvir
|
6.000 Hours
Interval 4.0 to 12.0
|
6.000 Hours
Interval 4.0 to 12.0
|
6.000 Hours
Interval 3.0 to 9.0
|
4.500 Hours
Interval 0.0 to 9.0
|
6.000 Hours
Interval 3.98 to 9.0
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)Population: PK set: all safety set participants except those who violated inclusion/exclusion criteria, deviated from protocol, or if data were unavailable/incomplete which influenced PK analysis.
AUC(0-last) is the area under the plasma concentration-time curve from time 0 to last measurable plasma concentration of odalasvir. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
Outcome measures
| Measure |
Cohort 1 (8 Weeks Genotype [GT1])
n=11 Participants
Cohort 1 (Participants without Cirrhosis) received single dose of AL-335 400 milligrams (mg) tablets once daily (QD), odalasvir (ODV) 50 mg tablet and simeprevir 100 mg tablet QD for 8 weeks.
|
Cohort 1b + Cohort 4 (8 Weeks GT1)
n=11 Participants
Cohort 1b (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets every other day (QOD) for 8 weeks; Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 8 weeks.
|
Cohort 2 (8 Weeks GT1)
n=16 Participants
Cohort 2 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
|
Cohort 3 (6 Weeks GT1)
n=6 Participants
Cohort 3 (Participants without Cirrhosis) received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD for 6 weeks.
|
Cohort 4 (12 Weeks GT1)
n=27 Participants
Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 12 weeks.
|
Cohort 5a (8 Weeks GT3)
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
|
Cohort 5b (12 Weeks GT3)
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 12 weeks.
|
Cohort 6,7,8 (8 Weeks GT1 F4)
Cohort 6 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks; Cohort 7 and Cohort 8 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 8 weeks.
|
Cohort 9 (12 Weeks GT1 F4)
Cohort 9 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
|
Cohort 11 (12 Weeks GT2 F4)
Cohort 11 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
AUC (0-last) of Odalasvir
|
11805.5 ng*h/ml
Standard Deviation 4902.6
|
8635.5 ng*h/ml
Standard Deviation 4656.7
|
8648.1 ng*h/ml
Standard Deviation 4161.1
|
7050.0 ng*h/ml
Standard Deviation 4001.4
|
8422.2 ng*h/ml
Standard Deviation 3617.8
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdosePopulation: PK set: all safety set participants except those who violated inclusion/exclusion criteria, deviated from protocol, or if data were unavailable/incomplete which influenced PK analysis.
AUC(0-24) is the area under the plasma concentration-time curve from time zero to time 24 hours for odalasvir. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
Outcome measures
| Measure |
Cohort 1 (8 Weeks Genotype [GT1])
n=11 Participants
Cohort 1 (Participants without Cirrhosis) received single dose of AL-335 400 milligrams (mg) tablets once daily (QD), odalasvir (ODV) 50 mg tablet and simeprevir 100 mg tablet QD for 8 weeks.
|
Cohort 1b + Cohort 4 (8 Weeks GT1)
n=11 Participants
Cohort 1b (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets every other day (QOD) for 8 weeks; Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 8 weeks.
|
Cohort 2 (8 Weeks GT1)
n=16 Participants
Cohort 2 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
|
Cohort 3 (6 Weeks GT1)
n=6 Participants
Cohort 3 (Participants without Cirrhosis) received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD for 6 weeks.
|
Cohort 4 (12 Weeks GT1)
n=27 Participants
Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 12 weeks.
|
Cohort 5a (8 Weeks GT3)
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
|
Cohort 5b (12 Weeks GT3)
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 12 weeks.
|
Cohort 6,7,8 (8 Weeks GT1 F4)
Cohort 6 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks; Cohort 7 and Cohort 8 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 8 weeks.
|
Cohort 9 (12 Weeks GT1 F4)
Cohort 9 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
|
Cohort 11 (12 Weeks GT2 F4)
Cohort 11 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
AUC (0-24) for Odalasvir
|
11805.5 ng*h/mL
Standard Deviation 4902.6
|
5530.0 ng*h/mL
Standard Deviation 2930.3
|
5393.8 ng*h/mL
Standard Deviation 2695.4
|
4048.3 ng*h/mL
Standard Deviation 2727.8
|
4924.1 ng*h/mL
Standard Deviation 2122.9
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)Population: PK set: all safety set participants except those who violated inclusion/exclusion criteria, deviated from protocol, or if data were unavailable/incomplete which influenced PK analysis.
Clast is the last measurable plasma concentration (Clast) of odalasvir. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
Outcome measures
| Measure |
Cohort 1 (8 Weeks Genotype [GT1])
n=11 Participants
Cohort 1 (Participants without Cirrhosis) received single dose of AL-335 400 milligrams (mg) tablets once daily (QD), odalasvir (ODV) 50 mg tablet and simeprevir 100 mg tablet QD for 8 weeks.
|
Cohort 1b + Cohort 4 (8 Weeks GT1)
n=11 Participants
Cohort 1b (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets every other day (QOD) for 8 weeks; Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 8 weeks.
|
Cohort 2 (8 Weeks GT1)
n=16 Participants
Cohort 2 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
|
Cohort 3 (6 Weeks GT1)
n=6 Participants
Cohort 3 (Participants without Cirrhosis) received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD for 6 weeks.
|
Cohort 4 (12 Weeks GT1)
n=27 Participants
Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 12 weeks.
|
Cohort 5a (8 Weeks GT3)
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
|
Cohort 5b (12 Weeks GT3)
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 12 weeks.
|
Cohort 6,7,8 (8 Weeks GT1 F4)
Cohort 6 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks; Cohort 7 and Cohort 8 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 8 weeks.
|
Cohort 9 (12 Weeks GT1 F4)
Cohort 9 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
|
Cohort 11 (12 Weeks GT2 F4)
Cohort 11 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Clast of Odalasvir
|
384.09 ng/ml
Standard Deviation 172.29
|
162.65 ng/ml
Standard Deviation 87.39
|
163.54 ng/ml
Standard Deviation 78.10
|
131.92 ng/ml
Standard Deviation 74.01
|
152.47 ng/ml
Standard Deviation 66.50
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)Population: PK set: all safety set participants except those who violated inclusion/exclusion criteria, deviated from protocol, or if data were unavailable/incomplete which influenced PK analysis.
Tlast is the time corresponding to last measurable plasma concentration of odalasvir. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
Outcome measures
| Measure |
Cohort 1 (8 Weeks Genotype [GT1])
n=11 Participants
Cohort 1 (Participants without Cirrhosis) received single dose of AL-335 400 milligrams (mg) tablets once daily (QD), odalasvir (ODV) 50 mg tablet and simeprevir 100 mg tablet QD for 8 weeks.
|
Cohort 1b + Cohort 4 (8 Weeks GT1)
n=11 Participants
Cohort 1b (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets every other day (QOD) for 8 weeks; Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 8 weeks.
|
Cohort 2 (8 Weeks GT1)
n=16 Participants
Cohort 2 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
|
Cohort 3 (6 Weeks GT1)
n=6 Participants
Cohort 3 (Participants without Cirrhosis) received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD for 6 weeks.
|
Cohort 4 (12 Weeks GT1)
n=27 Participants
Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 12 weeks.
|
Cohort 5a (8 Weeks GT3)
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
|
Cohort 5b (12 Weeks GT3)
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 12 weeks.
|
Cohort 6,7,8 (8 Weeks GT1 F4)
Cohort 6 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks; Cohort 7 and Cohort 8 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 8 weeks.
|
Cohort 9 (12 Weeks GT1 F4)
Cohort 9 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
|
Cohort 11 (12 Weeks GT2 F4)
Cohort 11 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Tlast of Odalasvir
|
24.00 Hours
Interval 24.0 to 24.1
|
47.60 Hours
Interval 47.5 to 47.7
|
47.50 Hours
Interval 47.4 to 47.9
|
47.80 Hours
Interval 47.4 to 48.0
|
47.50 Hours
Interval 47.5 to 47.9
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)Population: PK set: all safety set participants except those who violated inclusion/exclusion criteria, deviated from protocol, or if data were unavailable/incomplete which influenced PK analysis.
Css,avg is the average plasma concentration at steady state of odalasvir. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
Outcome measures
| Measure |
Cohort 1 (8 Weeks Genotype [GT1])
n=11 Participants
Cohort 1 (Participants without Cirrhosis) received single dose of AL-335 400 milligrams (mg) tablets once daily (QD), odalasvir (ODV) 50 mg tablet and simeprevir 100 mg tablet QD for 8 weeks.
|
Cohort 1b + Cohort 4 (8 Weeks GT1)
n=11 Participants
Cohort 1b (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets every other day (QOD) for 8 weeks; Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 8 weeks.
|
Cohort 2 (8 Weeks GT1)
n=16 Participants
Cohort 2 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
|
Cohort 3 (6 Weeks GT1)
n=6 Participants
Cohort 3 (Participants without Cirrhosis) received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD for 6 weeks.
|
Cohort 4 (12 Weeks GT1)
n=27 Participants
Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 12 weeks.
|
Cohort 5a (8 Weeks GT3)
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
|
Cohort 5b (12 Weeks GT3)
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 12 weeks.
|
Cohort 6,7,8 (8 Weeks GT1 F4)
Cohort 6 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks; Cohort 7 and Cohort 8 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 8 weeks.
|
Cohort 9 (12 Weeks GT1 F4)
Cohort 9 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
|
Cohort 11 (12 Weeks GT2 F4)
Cohort 11 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Average Plasma Concentration at Steady State (Css,Avg) of Odalasvir
|
491.55 ng/ml
Standard Deviation 203.85
|
181.60 ng/ml
Standard Deviation 97.99
|
181.58 ng/ml
Standard Deviation 87.25
|
147.40 ng/ml
Standard Deviation 83.86
|
176.86 ng/ml
Standard Deviation 75.91
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Follow up period (Up to Week 12 after end of treatment)Population: Safety set included all participants enrolled into study who had received at least 1 dose of any study drug, whether prematurely withdrawn from study or not.
Viral relapse is defined as participants SVR12, with HCV RNA \<LLOQ at the actual end of study drug treatment and confirmed HCV RNA greater than or equal to (\>=) LLOQ during follow up.
Outcome measures
| Measure |
Cohort 1 (8 Weeks Genotype [GT1])
n=20 Participants
Cohort 1 (Participants without Cirrhosis) received single dose of AL-335 400 milligrams (mg) tablets once daily (QD), odalasvir (ODV) 50 mg tablet and simeprevir 100 mg tablet QD for 8 weeks.
|
Cohort 1b + Cohort 4 (8 Weeks GT1)
n=25 Participants
Cohort 1b (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets every other day (QOD) for 8 weeks; Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 8 weeks.
|
Cohort 2 (8 Weeks GT1)
n=20 Participants
Cohort 2 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
|
Cohort 3 (6 Weeks GT1)
n=20 Participants
Cohort 3 (Participants without Cirrhosis) received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD for 6 weeks.
|
Cohort 4 (12 Weeks GT1)
n=8 Participants
Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 12 weeks.
|
Cohort 5a (8 Weeks GT3)
n=5 Participants
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
|
Cohort 5b (12 Weeks GT3)
n=14 Participants
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 12 weeks.
|
Cohort 6,7,8 (8 Weeks GT1 F4)
n=30 Participants
Cohort 6 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks; Cohort 7 and Cohort 8 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 8 weeks.
|
Cohort 9 (12 Weeks GT1 F4)
n=15 Participants
Cohort 9 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
|
Cohort 11 (12 Weeks GT2 F4)
n=4 Participants
Cohort 11 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Virologic Relapse During the Follow-up Period
|
0 Percentage of participants
|
16.0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
100.0 Percentage of participants
|
14.3 Percentage of participants
|
3.3 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to 12 weeksPopulation: Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
On-treatment failure was defined by participants who did not achieve SVR12 and with confirmed HCV RNA \>= LLOQ at the actual end of study drug treatment.
Outcome measures
| Measure |
Cohort 1 (8 Weeks Genotype [GT1])
n=20 Participants
Cohort 1 (Participants without Cirrhosis) received single dose of AL-335 400 milligrams (mg) tablets once daily (QD), odalasvir (ODV) 50 mg tablet and simeprevir 100 mg tablet QD for 8 weeks.
|
Cohort 1b + Cohort 4 (8 Weeks GT1)
n=25 Participants
Cohort 1b (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets every other day (QOD) for 8 weeks; Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 8 weeks.
|
Cohort 2 (8 Weeks GT1)
n=20 Participants
Cohort 2 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
|
Cohort 3 (6 Weeks GT1)
n=20 Participants
Cohort 3 (Participants without Cirrhosis) received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD for 6 weeks.
|
Cohort 4 (12 Weeks GT1)
n=8 Participants
Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 12 weeks.
|
Cohort 5a (8 Weeks GT3)
n=5 Participants
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
|
Cohort 5b (12 Weeks GT3)
n=14 Participants
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 12 weeks.
|
Cohort 6,7,8 (8 Weeks GT1 F4)
n=30 Participants
Cohort 6 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks; Cohort 7 and Cohort 8 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 8 weeks.
|
Cohort 9 (12 Weeks GT1 F4)
n=15 Participants
Cohort 9 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
|
Cohort 11 (12 Weeks GT2 F4)
n=4 Participants
Cohort 11 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With On-treatment Failure
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
12.5 Percentage of participants
|
0 Percentage of participants
|
7.1 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
SECONDARY outcome
Timeframe: Day 2, 3, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 and End of treatment (Cohort 3: 6 weeks; Cohort 1, Cohort 1b+ Cohort 4, Cohort 2, Cohort 5a, and Cohort 6, 7, 8: 8 weeks; Cohort 4, Cohort 5b, Cohort 9 and Cohort 11: 12 weeks)Population: Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
Percentage of participants who achieved HCV RNA less then (\<) LLOQ undetectable was reported.
Outcome measures
| Measure |
Cohort 1 (8 Weeks Genotype [GT1])
n=20 Participants
Cohort 1 (Participants without Cirrhosis) received single dose of AL-335 400 milligrams (mg) tablets once daily (QD), odalasvir (ODV) 50 mg tablet and simeprevir 100 mg tablet QD for 8 weeks.
|
Cohort 1b + Cohort 4 (8 Weeks GT1)
n=25 Participants
Cohort 1b (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets every other day (QOD) for 8 weeks; Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 8 weeks.
|
Cohort 2 (8 Weeks GT1)
n=20 Participants
Cohort 2 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
|
Cohort 3 (6 Weeks GT1)
n=20 Participants
Cohort 3 (Participants without Cirrhosis) received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD for 6 weeks.
|
Cohort 4 (12 Weeks GT1)
n=8 Participants
Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 12 weeks.
|
Cohort 5a (8 Weeks GT3)
n=5 Participants
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
|
Cohort 5b (12 Weeks GT3)
n=14 Participants
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 12 weeks.
|
Cohort 6,7,8 (8 Weeks GT1 F4)
n=30 Participants
Cohort 6 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks; Cohort 7 and Cohort 8 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 8 weeks.
|
Cohort 9 (12 Weeks GT1 F4)
n=15 Participants
Cohort 9 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
|
Cohort 11 (12 Weeks GT2 F4)
n=4 Participants
Cohort 11 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable
Week 9
|
NA Percentage of participants
NA indicates that data was not collected at this timepoint since participants in this arm ended treatment at week 8.
|
NA Percentage of participants
NA indicates that data was not collected at this timepoint since participants in this arm ended treatment at week 8.
|
NA Percentage of participants
NA indicates that data was not collected at this timepoint since participants in this arm ended treatment at week 8.
|
NA Percentage of participants
NA indicates that data was not collected at this timepoint since participants in this arm ended treatment at week 6.
|
87.5 Percentage of participants
|
NA Percentage of participants
NA indicates that data was not collected at this timepoint since participants in this arm ended treatment at week 8.
|
92.9 Percentage of participants
|
NA Percentage of participants
NA indicates that data was not collected at this timepoint since participants in this arm ended treatment at week 8.
|
93.3 Percentage of participants
|
100 Percentage of participants
|
|
Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable
Day 2
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable
Day 3
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
5.0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
6.7 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable
Week 1
|
5.0 Percentage of participants
|
20.0 Percentage of participants
|
0 Percentage of participants
|
30.0 Percentage of participants
|
12.5 Percentage of participants
|
20.0 Percentage of participants
|
35.7 Percentage of participants
|
16.7 Percentage of participants
|
13.3 Percentage of participants
|
25.0 Percentage of participants
|
|
Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable
Week 2
|
35.0 Percentage of participants
|
44.0 Percentage of participants
|
45.0 Percentage of participants
|
70.0 Percentage of participants
|
25.0 Percentage of participants
|
40.0 Percentage of participants
|
64.3 Percentage of participants
|
50.0 Percentage of participants
|
66.7 Percentage of participants
|
75.0 Percentage of participants
|
|
Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable
Week 3
|
70.0 Percentage of participants
|
76.0 Percentage of participants
|
75.0 Percentage of participants
|
80.0 Percentage of participants
|
62.5 Percentage of participants
|
60.0 Percentage of participants
|
85.7 Percentage of participants
|
73.3 Percentage of participants
|
86.7 Percentage of participants
|
100 Percentage of participants
|
|
Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable
Week 4
|
80.0 Percentage of participants
|
92.0 Percentage of participants
|
90.0 Percentage of participants
|
85.0 Percentage of participants
|
87.5 Percentage of participants
|
60.0 Percentage of participants
|
92.9 Percentage of participants
|
80.0 Percentage of participants
|
86.7 Percentage of participants
|
100 Percentage of participants
|
|
Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable
Week 5
|
100 Percentage of participants
|
96.0 Percentage of participants
|
100 Percentage of participants
|
90.0 Percentage of participants
|
100 Percentage of participants
|
80.0 Percentage of participants
|
92.9 Percentage of participants
|
90.0 Percentage of participants
|
100 Percentage of participants
|
100 Percentage of participants
|
|
Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable
Week 6
|
90.0 Percentage of participants
|
100 Percentage of participants
|
85.0 Percentage of participants
|
90.0 Percentage of participants
|
100 Percentage of participants
|
100 Percentage of participants
|
92.9 Percentage of participants
|
96.7 Percentage of participants
|
100 Percentage of participants
|
100 Percentage of participants
|
|
Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable
Week 7
|
90.0 Percentage of participants
|
96.0 Percentage of participants
|
95.0 Percentage of participants
|
NA Percentage of participants
NA indicates that data was not collected at this timepoint since participants in this arm ended treatment at week 6.
|
100 Percentage of participants
|
80.0 Percentage of participants
|
85.7 Percentage of participants
|
100 Percentage of participants
|
100 Percentage of participants
|
100 Percentage of participants
|
|
Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable
Week 8
|
95.0 Percentage of participants
|
100 Percentage of participants
|
100 Percentage of participants
|
NA Percentage of participants
NA indicates that data was not collected at this timepoint since participants in this arm ended treatment at week 6.
|
87.5 Percentage of participants
|
100 Percentage of participants
|
85.7 Percentage of participants
|
100 Percentage of participants
|
93.3 Percentage of participants
|
100 Percentage of participants
|
|
Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable
Week 10
|
NA Percentage of participants
NA indicates that data was not collected at this timepoint since participants in this arm ended treatment at week 8.
|
NA Percentage of participants
NA indicates that data was not collected at this timepoint since participants in this arm ended treatment at week 8.
|
NA Percentage of participants
NA indicates that data was not collected at this timepoint since participants in this arm ended treatment at week 8.
|
NA Percentage of participants
NA indicates that data was not collected at this timepoint since participants in this arm ended treatment at week 6.
|
87.5 Percentage of participants
|
NA Percentage of participants
NA indicates that data was not collected at this timepoint since participants in this arm ended treatment at week 8.
|
92.9 Percentage of participants
|
NA Percentage of participants
NA indicates that data was not collected at this timepoint since participants in this arm ended treatment at week 8.
|
93.3 Percentage of participants
|
100 Percentage of participants
|
|
Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable
Week 11
|
NA Percentage of participants
NA indicates that data was not collected at this timepoint since participants in this arm ended treatment at week 8.
|
NA Percentage of participants
NA indicates that data was not collected at this timepoint since participants in this arm ended treatment at week 8.
|
NA Percentage of participants
NA indicates that data was not collected at this timepoint since participants in this arm ended treatment at week 8.
|
NA Percentage of participants
NA indicates that data was not collected at this timepoint since participants in this arm ended treatment at week 6.
|
87.5 Percentage of participants
|
NA Percentage of participants
NA indicates that data was not collected at this timepoint since participants in this arm ended treatment at week 8.
|
92.9 Percentage of participants
|
NA Percentage of participants
NA indicates that data was not collected at this timepoint since participants in this arm ended treatment at week 8.
|
86.7 Percentage of participants
|
100 Percentage of participants
|
|
Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable
Week 12
|
NA Percentage of participants
NA indicates that data was not collected at this timepoint since participants in this arm ended treatment at week 8.
|
NA Percentage of participants
NA indicates that data was not collected at this timepoint since participants in this arm ended treatment at week 8.
|
NA Percentage of participants
NA indicates that data was not collected at this timepoint since participants in this arm ended treatment at week 8.
|
NA Percentage of participants
NA indicates that data was not collected at this timepoint since participants in this arm ended treatment at week 6.
|
87.5 Percentage of participants
|
NA Percentage of participants
NA indicates that data was not collected at this timepoint since participants in this arm ended treatment at week 8.
|
85.7 Percentage of participants
|
NA Percentage of participants
NA indicates that data was not collected at this timepoint since participants in this arm ended treatment at week 8.
|
93.3 Percentage of participants
|
100 Percentage of participants
|
|
Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable
End of treatment
|
95.0 Percentage of participants
|
100 Percentage of participants
|
100 Percentage of participants
|
90.0 Percentage of participants
|
87.5 Percentage of participants
|
100 Percentage of participants
|
85.7 Percentage of participants
|
100 Percentage of participants
|
93.3 Percentage of participants
|
100 Percentage of participants
|
SECONDARY outcome
Timeframe: Day 2, 3, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 and End of treatment (Cohort 3: 6 weeks; Cohort 1, Cohort 1b+ Cohort 4, Cohort 2, Cohort 5a, and Cohort 6, 7, 8: 8 weeks; Cohort 4, Cohort 5b, Cohort 9 and Cohort 11: 12 weeks)Population: Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
Percentage of participants who achieved HCV RNA \<LLOQ was reported.
Outcome measures
| Measure |
Cohort 1 (8 Weeks Genotype [GT1])
n=20 Participants
Cohort 1 (Participants without Cirrhosis) received single dose of AL-335 400 milligrams (mg) tablets once daily (QD), odalasvir (ODV) 50 mg tablet and simeprevir 100 mg tablet QD for 8 weeks.
|
Cohort 1b + Cohort 4 (8 Weeks GT1)
n=25 Participants
Cohort 1b (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets every other day (QOD) for 8 weeks; Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 8 weeks.
|
Cohort 2 (8 Weeks GT1)
n=20 Participants
Cohort 2 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
|
Cohort 3 (6 Weeks GT1)
n=20 Participants
Cohort 3 (Participants without Cirrhosis) received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD for 6 weeks.
|
Cohort 4 (12 Weeks GT1)
n=8 Participants
Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 12 weeks.
|
Cohort 5a (8 Weeks GT3)
n=5 Participants
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
|
Cohort 5b (12 Weeks GT3)
n=14 Participants
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 12 weeks.
|
Cohort 6,7,8 (8 Weeks GT1 F4)
n=30 Participants
Cohort 6 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks; Cohort 7 and Cohort 8 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 8 weeks.
|
Cohort 9 (12 Weeks GT1 F4)
n=15 Participants
Cohort 9 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
|
Cohort 11 (12 Weeks GT2 F4)
n=4 Participants
Cohort 11 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Who Achieved HCV RNA <LLOQ
Week 11
|
NA Percentage of participants
NA indicates that data was not collected at this timepoint since participants in this arm ended treatment at week 8.
|
NA Percentage of participants
NA indicates that data was not collected at this timepoint since participants in this arm ended treatment at week 8.
|
NA Percentage of participants
NA indicates that data was not collected at this timepoint since participants in this arm ended treatment at week 8.
|
NA Percentage of participants
NA indicates that data was not collected at this timepoint since participants in this arm ended treatment at week 6.
|
87.5 Percentage of participants
|
NA Percentage of participants
NA indicates that data was not collected at this timepoint since participants in this arm ended treatment at week 8.
|
92.9 Percentage of participants
|
NA Percentage of participants
NA indicates that data was not collected at this timepoint since participants in this arm ended treatment at week 8.
|
86.7 Percentage of participants
|
100 Percentage of participants
|
|
Percentage of Participants Who Achieved HCV RNA <LLOQ
Week 12
|
NA Percentage of participants
NA indicates that data was not collected at this timepoint since participants in this arm ended treatment at week 8.
|
NA Percentage of participants
NA indicates that data was not collected at this timepoint since participants in this arm ended treatment at week 8.
|
NA Percentage of participants
NA indicates that the data was not estimable for the specified timepoint.
|
NA Percentage of participants
NA indicates that data was not collected at this timepoint since participants in this arm ended treatment at week 6.
|
87.5 Percentage of participants
|
NA Percentage of participants
NA indicates that data was not collected at this timepoint since participants in this arm ended treatment at week 8.
|
78.6 Percentage of participants
|
NA Percentage of participants
NA indicates that data was not collected at this timepoint since participants in this arm ended treatment at week 8.
|
93.3 Percentage of participants
|
100 Percentage of participants
|
|
Percentage of Participants Who Achieved HCV RNA <LLOQ
End of treatment
|
85.0 Percentage of participants
|
96.0 Percentage of participants
|
100 Percentage of participants
|
80.0 Percentage of participants
|
87.5 Percentage of participants
|
100 Percentage of participants
|
78.6 Percentage of participants
|
100 Percentage of participants
|
93.3 Percentage of participants
|
100 Percentage of participants
|
|
Percentage of Participants Who Achieved HCV RNA <LLOQ
Day 2
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Who Achieved HCV RNA <LLOQ
Day 3
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Who Achieved HCV RNA <LLOQ
Week 1
|
0 Percentage of participants
|
8.0 Percentage of participants
|
0 Percentage of participants
|
10.0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
14.3 Percentage of participants
|
16.7 Percentage of participants
|
13.3 Percentage of participants
|
25.0 Percentage of participants
|
|
Percentage of Participants Who Achieved HCV RNA <LLOQ
Week 2
|
20.0 Percentage of participants
|
20.0 Percentage of participants
|
15.0 Percentage of participants
|
40.0 Percentage of participants
|
0 Percentage of participants
|
20.0 Percentage of participants
|
42.9 Percentage of participants
|
50.0 Percentage of participants
|
66.7 Percentage of participants
|
75.0 Percentage of participants
|
|
Percentage of Participants Who Achieved HCV RNA <LLOQ
Week 3
|
40.0 Percentage of participants
|
40.0 Percentage of participants
|
45.0 Percentage of participants
|
65.0 Percentage of participants
|
37.5 Percentage of participants
|
60.0 Percentage of participants
|
50.0 Percentage of participants
|
73.3 Percentage of participants
|
86.7 Percentage of participants
|
100 Percentage of participants
|
|
Percentage of Participants Who Achieved HCV RNA <LLOQ
Week 4
|
55.0 Percentage of participants
|
52.0 Percentage of participants
|
60.0 Percentage of participants
|
80.0 Percentage of participants
|
62.5 Percentage of participants
|
40.0 Percentage of participants
|
78.6 Percentage of participants
|
80.0 Percentage of participants
|
86.7 Percentage of participants
|
100 Percentage of participants
|
|
Percentage of Participants Who Achieved HCV RNA <LLOQ
Week 5
|
75.0 Percentage of participants
|
96.0 Percentage of participants
|
85.0 Percentage of participants
|
85.0 Percentage of participants
|
75.0 Percentage of participants
|
80.0 Percentage of participants
|
85.7 Percentage of participants
|
90.0 Percentage of participants
|
100 Percentage of participants
|
100 Percentage of participants
|
|
Percentage of Participants Who Achieved HCV RNA <LLOQ
Week 6
|
80.0 Percentage of participants
|
88.0 Percentage of participants
|
85.0 Percentage of participants
|
80.0 Percentage of participants
|
87.5 Percentage of participants
|
80.0 Percentage of participants
|
92.9 Percentage of participants
|
96.7 Percentage of participants
|
100 Percentage of participants
|
100 Percentage of participants
|
|
Percentage of Participants Who Achieved HCV RNA <LLOQ
Week 7
|
80.0 Percentage of participants
|
92.0 Percentage of participants
|
95.0 Percentage of participants
|
NA Percentage of participants
NA indicates that data was not collected at this timepoint since participants in this arm ended treatment at week 6.
|
87.5 Percentage of participants
|
80.0 Percentage of participants
|
85.7 Percentage of participants
|
100 Percentage of participants
|
100 Percentage of participants
|
100 Percentage of participants
|
|
Percentage of Participants Who Achieved HCV RNA <LLOQ
Week 8
|
85.0 Percentage of participants
|
96.0 Percentage of participants
|
100 Percentage of participants
|
NA Percentage of participants
NA indicates that data was not collected at this timepoint since participants in this arm ended treatment at week 6.
|
87.5 Percentage of participants
|
100 Percentage of participants
|
85.7 Percentage of participants
|
100 Percentage of participants
|
93.3 Percentage of participants
|
100 Percentage of participants
|
|
Percentage of Participants Who Achieved HCV RNA <LLOQ
Week 9
|
NA Percentage of participants
NA indicates that data was not collected at this timepoint since participants in this arm ended treatment at week 8.
|
NA Percentage of participants
NA indicates that data was not collected at this timepoint since participants in this arm ended treatment at week 8.
|
NA Percentage of participants
NA indicates that data was not collected at this timepoint since participants in this arm ended treatment at week 8.
|
NA Percentage of participants
NA indicates that data was not collected at this timepoint since participants in this arm ended treatment at week 6.
|
87.5 Percentage of participants
|
NA Percentage of participants
NA indicates that data was not collected at this timepoint since participants in this arm ended treatment at week 8.
|
92.9 Percentage of participants
|
NA Percentage of participants
NA indicates that data was not collected at this timepoint since participants in this arm ended treatment at week 8.
|
93.3 Percentage of participants
|
100 Percentage of participants
|
|
Percentage of Participants Who Achieved HCV RNA <LLOQ
Week 10
|
NA Percentage of participants
NA indicates that data was not collected at this timepoint since participants in this arm ended treatment at week 8.
|
NA Percentage of participants
NA indicates that data was not collected at this timepoint since participants in this arm ended treatment at week 8.
|
NA Percentage of participants
NA indicates that data was not collected at this timepoint since participants in this arm ended treatment at week 8.
|
NA Percentage of participants
NA indicates that data was not collected at this timepoint since participants in this arm ended treatment at week 6.
|
87.5 Percentage of participants
|
NA Percentage of participants
NA indicates that data was not collected at this timepoint since participants in this arm ended treatment at week 8.
|
92.9 Percentage of participants
|
NA Percentage of participants
NA indicates that data was not collected at this timepoint since participants in this arm ended treatment at week 8.
|
93.3 Percentage of participants
|
100 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to Week 24 (follow up visit)Population: Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not. Data was not collected and analyzed for this outcome measure as per the change in planned analysis.
Time to achieve undetectable HCV RNA or \< LLOQ HCV RNA was reported.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to Week 24 (Follow up visit)Population: Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not. Participants who had virologic failure were included in this outcome measure.
Sequencing of the HCV nonstructural protein 3/4A (NS3/4A), nonstructural protein 5A (NS5A) and nonstructural protein 5B (NS5B) genes was done to identify pre-existing sequence polymorphisms and characterize emerging HCV viral variants in participants with virologic failure.
Outcome measures
| Measure |
Cohort 1 (8 Weeks Genotype [GT1])
Cohort 1 (Participants without Cirrhosis) received single dose of AL-335 400 milligrams (mg) tablets once daily (QD), odalasvir (ODV) 50 mg tablet and simeprevir 100 mg tablet QD for 8 weeks.
|
Cohort 1b + Cohort 4 (8 Weeks GT1)
n=4 Participants
Cohort 1b (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets every other day (QOD) for 8 weeks; Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 8 weeks.
|
Cohort 2 (8 Weeks GT1)
Cohort 2 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
|
Cohort 3 (6 Weeks GT1)
Cohort 3 (Participants without Cirrhosis) received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD for 6 weeks.
|
Cohort 4 (12 Weeks GT1)
n=1 Participants
Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 12 weeks.
|
Cohort 5a (8 Weeks GT3)
n=5 Participants
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
|
Cohort 5b (12 Weeks GT3)
n=3 Participants
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 12 weeks.
|
Cohort 6,7,8 (8 Weeks GT1 F4)
n=1 Participants
Cohort 6 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks; Cohort 7 and Cohort 8 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 8 weeks.
|
Cohort 9 (12 Weeks GT1 F4)
Cohort 9 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
|
Cohort 11 (12 Weeks GT2 F4)
Cohort 11 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With HCV Nonstructural Protein NS5A, NS5B, and NS3/4A Sequence in Participants With Virologic Failure
|
—
|
4 Participants
|
—
|
—
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
—
|
—
|
Adverse Events
Cohort 1 (8 Weeks Genotype [GT1])
Serious events: 1 serious events
Other events: 17 other events
Deaths: 0 deaths
Cohort 1b + Cohort 4 (8 Weeks GT1)
Serious events: 2 serious events
Other events: 20 other events
Deaths: 0 deaths
Cohort 2 (8 Weeks GT1)
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Cohort 3 (6 Weeks GT1)
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Cohort 4 (12 Weeks GT1)
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Cohort 5a (8 Weeks GT3)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Cohort 5b (12 Weeks GT3)
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Cohort 6,7,8 (8 Weeks GT1 F4)
Serious events: 1 serious events
Other events: 18 other events
Deaths: 0 deaths
Cohort 9 (12 Weeks GT1 F4)
Serious events: 2 serious events
Other events: 10 other events
Deaths: 0 deaths
Cohort 11 (12 Weeks GT2 F4)
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1 (8 Weeks Genotype [GT1])
n=20 participants at risk
Cohort 1 (Participants without Cirrhosis) received single dose of AL-335 400 milligrams (mg) tablets once daily (QD), odalasvir (ODV) 50 mg tablet and simeprevir 100 mg tablet QD for 8 weeks.
|
Cohort 1b + Cohort 4 (8 Weeks GT1)
n=25 participants at risk
Cohort 1b (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets every other day (QOD) for 8 weeks; Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 8 weeks.
|
Cohort 2 (8 Weeks GT1)
n=20 participants at risk
Cohort 2 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
|
Cohort 3 (6 Weeks GT1)
n=20 participants at risk
Cohort 3 (Participants without Cirrhosis) received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD for 6 weeks
|
Cohort 4 (12 Weeks GT1)
n=8 participants at risk
Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 12 weeks.
|
Cohort 5a (8 Weeks GT3)
n=5 participants at risk
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
|
Cohort 5b (12 Weeks GT3)
n=14 participants at risk
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 12 weeks.
|
Cohort 6,7,8 (8 Weeks GT1 F4)
n=30 participants at risk
Cohort 6 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks; Cohort 7 and Cohort 8 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 8 weeks.
|
Cohort 9 (12 Weeks GT1 F4)
n=15 participants at risk
Cohort 9 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
|
Cohort 11 (12 Weeks GT2 F4)
n=4 participants at risk
Cohort 11 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Atrioventricular Block Second Degree
|
5.0%
1/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
General disorders
Pain
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
3.3%
1/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
4.0%
1/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
25.0%
1/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
6.7%
1/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Investigations
Alanine Aminotransferase Increased
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
6.7%
1/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Investigations
Aspartate Aminotransferase Increased
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
6.7%
1/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional Cell Carcinoma Urethra
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
4.0%
1/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
Other adverse events
| Measure |
Cohort 1 (8 Weeks Genotype [GT1])
n=20 participants at risk
Cohort 1 (Participants without Cirrhosis) received single dose of AL-335 400 milligrams (mg) tablets once daily (QD), odalasvir (ODV) 50 mg tablet and simeprevir 100 mg tablet QD for 8 weeks.
|
Cohort 1b + Cohort 4 (8 Weeks GT1)
n=25 participants at risk
Cohort 1b (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets every other day (QOD) for 8 weeks; Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 8 weeks.
|
Cohort 2 (8 Weeks GT1)
n=20 participants at risk
Cohort 2 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
|
Cohort 3 (6 Weeks GT1)
n=20 participants at risk
Cohort 3 (Participants without Cirrhosis) received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD for 6 weeks
|
Cohort 4 (12 Weeks GT1)
n=8 participants at risk
Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 12 weeks.
|
Cohort 5a (8 Weeks GT3)
n=5 participants at risk
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
|
Cohort 5b (12 Weeks GT3)
n=14 participants at risk
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 12 weeks.
|
Cohort 6,7,8 (8 Weeks GT1 F4)
n=30 participants at risk
Cohort 6 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks; Cohort 7 and Cohort 8 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 8 weeks.
|
Cohort 9 (12 Weeks GT1 F4)
n=15 participants at risk
Cohort 9 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
|
Cohort 11 (12 Weeks GT2 F4)
n=4 participants at risk
Cohort 11 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Rotator Cuff Syndrome
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
6.7%
1/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
6.7%
1/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
5.0%
1/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
5.0%
1/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Cardiac disorders
Atrioventricular Block First Degree
|
5.0%
1/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
4.0%
1/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Cardiac disorders
Palpitations
|
5.0%
1/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
12.5%
1/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
3.3%
1/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Cardiac disorders
Supraventricular Tachycardia
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
12.5%
1/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Congenital, familial and genetic disorders
Porphyria Non-Acute
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
25.0%
1/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Ear and labyrinth disorders
Ear Discomfort
|
5.0%
1/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
4.0%
1/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Ear and labyrinth disorders
Ear Pruritus
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
25.0%
1/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Eye disorders
Dry Eye
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
4.0%
1/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
25.0%
1/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Eye disorders
Erythema of Eyelid
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
3.3%
1/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Eye disorders
Eye Irritation
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
10.0%
2/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Eye disorders
Eye Pruritus
|
5.0%
1/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
20.0%
1/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Eye disorders
Vision Blurred
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
25.0%
1/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Eye disorders
Visual Impairment
|
5.0%
1/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Gastrointestinal disorders
Abdominal Discomfort
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
7.1%
1/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Gastrointestinal disorders
Abdominal Distension
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
7.1%
1/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Gastrointestinal disorders
Abdominal Pain
|
15.0%
3/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
12.5%
1/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
7.1%
1/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
3.3%
1/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
25.0%
1/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Gastrointestinal disorders
Abdominal Pain Lower
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
12.5%
1/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
5.0%
1/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Gastrointestinal disorders
Constipation
|
5.0%
1/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
4.0%
1/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
12.5%
1/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Gastrointestinal disorders
Dental Caries
|
5.0%
1/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Gastrointestinal disorders
Diarrhoea
|
5.0%
1/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
8.0%
2/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
5.0%
1/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
12.5%
1/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
7.1%
1/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
10.0%
3/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
6.7%
1/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Gastrointestinal disorders
Dry Mouth
|
5.0%
1/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
4.0%
1/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
5.0%
1/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
25.0%
1/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
4.0%
1/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
5.0%
1/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
25.0%
2/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
7.1%
1/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
5.0%
1/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
3.3%
1/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
5.0%
1/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Gastrointestinal disorders
Loose Tooth
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
3.3%
1/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Gastrointestinal disorders
Nausea
|
10.0%
2/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
4.0%
1/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
12.5%
1/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
10.0%
3/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Gastrointestinal disorders
Noninfective Sialoadenitis
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
7.1%
1/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Gastrointestinal disorders
Salivary Gland Calculus
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
7.1%
1/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
4.0%
1/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
5.0%
1/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
12.5%
1/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
3.3%
1/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Gastrointestinal disorders
Vomiting
|
5.0%
1/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
4.0%
1/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
3.3%
1/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
6.7%
1/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
25.0%
1/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
General disorders
Chest Discomfort
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
7.1%
1/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
3.3%
1/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
General disorders
Chest Pain
|
5.0%
1/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
5.0%
1/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
7.1%
1/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
General disorders
Fatigue
|
30.0%
6/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
16.0%
4/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
10.0%
2/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
15.0%
3/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
25.0%
2/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
42.9%
6/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
10.0%
3/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
6.7%
1/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
50.0%
2/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
General disorders
Feeling Abnormal
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
5.0%
1/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
General disorders
Pain
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
3.3%
1/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
General disorders
Peripheral Swelling
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
4.0%
1/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
General disorders
Pyrexia
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
5.0%
1/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
General disorders
Swelling
|
5.0%
1/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
General disorders
Vessel Puncture Site Bruise
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
4.0%
1/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
5.0%
1/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
5.0%
1/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
7.1%
1/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
6.7%
2/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
General disorders
Vessel Puncture Site Haematoma
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
3.3%
1/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
General disorders
Vessel Puncture Site Phlebitis
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
7.1%
1/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Infections and infestations
Angular Cheilitis
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
12.5%
1/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
7.1%
1/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
6.7%
1/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
25.0%
1/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Infections and infestations
Conjunctivitis
|
5.0%
1/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
7.1%
1/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Infections and infestations
Conjunctivitis Viral
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
7.1%
1/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
5.0%
1/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Infections and infestations
Furuncle
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
4.0%
1/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Infections and infestations
Gastroenteritis
|
5.0%
1/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
6.7%
1/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Infections and infestations
Gingivitis
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
4.0%
1/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Infections and infestations
Hordeolum
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
4.0%
1/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Infections and infestations
Influenza
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
6.7%
1/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Infections and infestations
Laryngitis
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
5.0%
1/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Infections and infestations
Lower Respiratory Tract Infection
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
5.0%
1/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
20.0%
1/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
7.1%
1/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
50.0%
2/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
25.0%
1/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
12.5%
1/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Infections and infestations
Rash Pustular
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
7.1%
1/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Infections and infestations
Respiratory Tract Infection
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
5.0%
1/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
7.1%
1/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Infections and infestations
Respiratory Tract Infection Viral
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
7.1%
1/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Infections and infestations
Rhinitis
|
5.0%
1/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
3.3%
1/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Infections and infestations
Skin Infection
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
3.3%
1/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
5.0%
1/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Infections and infestations
Tooth Abscess
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
5.0%
1/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Infections and infestations
Tooth Infection
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
12.5%
1/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
30.0%
6/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
12.0%
3/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
5.0%
1/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
5.0%
1/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
37.5%
3/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
40.0%
2/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
28.6%
4/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
10.0%
3/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
25.0%
1/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
6.7%
2/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Infections and infestations
Viral Infection
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
5.0%
1/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
12.5%
1/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Infections and infestations
Wound Infection
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
5.0%
1/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
3.3%
1/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Injury, poisoning and procedural complications
Accidental Overdose
|
5.0%
1/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
4.0%
1/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
5.0%
1/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
15.0%
3/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
3.3%
1/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Injury, poisoning and procedural complications
Scratch
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
5.0%
1/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Injury, poisoning and procedural complications
Chest Injury
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
4.0%
1/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Injury, poisoning and procedural complications
Contusion
|
10.0%
2/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
8.0%
2/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
5.0%
1/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
5.0%
1/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
13.3%
4/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Injury, poisoning and procedural complications
Epicondylitis
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
12.5%
1/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Injury, poisoning and procedural complications
Eye Contusion
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
5.0%
1/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Injury, poisoning and procedural complications
Joint Injury
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
6.7%
1/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
4.0%
1/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
10.0%
2/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
20.0%
1/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
7.1%
1/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
6.7%
2/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Injury, poisoning and procedural complications
Ligament Sprain
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
4.0%
1/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
5.0%
1/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
3.3%
1/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Injury, poisoning and procedural complications
Limb Injury
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
5.0%
1/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
7.1%
1/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Injury, poisoning and procedural complications
Lip Injury
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
7.1%
1/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Injury, poisoning and procedural complications
Muscle Strain
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
7.1%
1/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Injury, poisoning and procedural complications
Skin Abrasion
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
5.0%
1/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
3.3%
1/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
6.7%
1/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Injury, poisoning and procedural complications
Sunburn
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
12.5%
1/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Injury, poisoning and procedural complications
Thermal Burn
|
5.0%
1/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
7.1%
1/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
3.3%
1/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Injury, poisoning and procedural complications
Tooth Fracture
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
5.0%
1/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
5.0%
1/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Investigations
Blood Creatine Phosphokinase Increase
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
6.7%
2/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
6.7%
1/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Investigations
Blood Pressure Increased
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
3.3%
1/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
25.0%
1/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Investigations
Ejection Fraction Decreased
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
6.7%
1/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Investigations
Electrocardiogram Pr Prolongation
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
3.3%
1/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Investigations
Lipase Increased
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
3.3%
1/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Metabolism and nutrition disorders
Appetite Disorder
|
5.0%
1/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
12.5%
1/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
7.1%
1/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Metabolism and nutrition disorders
Hyperphagia
|
5.0%
1/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Metabolism and nutrition disorders
Increased Appetite
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
4.0%
1/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
5.0%
1/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
20.0%
1/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
3.3%
1/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
25.0%
1/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
5.0%
1/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
4.0%
1/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
10.0%
2/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
5.0%
1/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
12.5%
1/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
21.4%
3/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
3.3%
1/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
6.7%
1/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Musculoskeletal and connective tissue disorders
Joint Stiffness
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
3.3%
1/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
6.7%
1/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Musculoskeletal and connective tissue disorders
Muscle Tightness
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
7.1%
1/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
4.0%
1/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
12.5%
1/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
3.3%
1/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
5.0%
1/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Stiffness
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
20.0%
1/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
3.3%
1/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.0%
1/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
4.0%
1/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
5.0%
1/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
12.5%
1/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
3.3%
1/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
6.7%
1/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
4.0%
1/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
20.0%
1/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
7.1%
1/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
6.7%
1/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
12.5%
1/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
7.1%
1/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal Cell Carcinoma
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
6.7%
1/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Nervous system disorders
Burning Sensation
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
7.1%
1/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Nervous system disorders
Disturbance in Attention
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
5.0%
1/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Nervous system disorders
Dizziness
|
5.0%
1/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
4.0%
1/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
5.0%
1/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
12.5%
1/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
7.1%
1/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
6.7%
1/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
5.0%
1/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Nervous system disorders
Headache
|
40.0%
8/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
20.0%
5/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
10.0%
2/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
15.0%
3/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
50.0%
4/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
40.0%
2/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
21.4%
3/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
6.7%
2/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
13.3%
2/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
25.0%
1/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Nervous system disorders
Hypogeusia
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
25.0%
1/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Nervous system disorders
Hyposmia
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
25.0%
1/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
4.0%
1/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
25.0%
2/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
7.1%
1/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Nervous system disorders
Memory Impairment
|
5.0%
1/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
5.0%
1/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Nervous system disorders
Migraine
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
3.3%
1/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
4.0%
1/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
5.0%
1/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
12.5%
1/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
7.1%
1/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
4.0%
1/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
5.0%
1/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
12.5%
1/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Nervous system disorders
Sensory Disturbance
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
12.5%
1/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Nervous system disorders
Tension Headache
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
5.0%
1/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Psychiatric disorders
Abnormal Dreams
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
7.1%
1/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Psychiatric disorders
Anxiety
|
10.0%
2/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
7.1%
1/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Psychiatric disorders
Depressed Mood
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
7.1%
1/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Psychiatric disorders
Dysphoria
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
12.5%
1/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Psychiatric disorders
Flat Affect
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
4.0%
1/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Psychiatric disorders
Insomnia
|
5.0%
1/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
4.0%
1/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
15.0%
3/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
3.3%
1/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Psychiatric disorders
Irritability
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
7.1%
1/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Psychiatric disorders
Libido Decreased
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
6.7%
1/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Psychiatric disorders
Nightmare
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
12.5%
1/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Psychiatric disorders
Panic Attack
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
7.1%
1/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Psychiatric disorders
Sleep Disorder
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
6.7%
2/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Renal and urinary disorders
Micturition Urgency
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
5.0%
1/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Renal and urinary disorders
Polyuria
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
7.1%
1/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
3.3%
1/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Renal and urinary disorders
Renal Colic
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
4.0%
1/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Reproductive system and breast disorders
Vaginal Discharge
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
3.3%
1/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
12.5%
1/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.0%
1/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
8.0%
2/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
5.0%
1/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
10.0%
2/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
12.5%
1/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
6.7%
2/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Respiratory, thoracic and mediastinal disorders
Dry Throat
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
25.0%
1/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
25.0%
1/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
3.3%
1/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
3.3%
1/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
25.0%
2/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
6.7%
1/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
5.0%
1/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
5.0%
1/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
12.5%
1/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
20.0%
1/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
7.1%
1/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
10.0%
2/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
4.0%
1/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
12.5%
1/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus Congestion
|
5.0%
1/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
12.5%
1/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
3.3%
1/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Respiratory, thoracic and mediastinal disorders
Throat Irritation
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
25.0%
1/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-Airway Cough Syndrome
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
5.0%
1/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
12.5%
1/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Skin and subcutaneous tissue disorders
Dermal Cyst
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
4.0%
1/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
25.0%
1/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Skin and subcutaneous tissue disorders
Dermatitis Atopic
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
5.0%
1/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Skin and subcutaneous tissue disorders
Dermatitis Contact
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
3.3%
1/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
12.5%
1/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
5.0%
1/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
25.0%
1/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Skin and subcutaneous tissue disorders
Hand Dermatitis
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
25.0%
1/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
12.5%
1/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Skin and subcutaneous tissue disorders
Mechanical Urticaria
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
4.0%
1/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Skin and subcutaneous tissue disorders
Night Sweats
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
7.1%
1/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity Reaction
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
6.7%
1/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.0%
1/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
7.1%
1/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
25.0%
1/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
5.0%
1/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
12.5%
1/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
3.3%
1/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Skin and subcutaneous tissue disorders
Rash Papular
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
7.1%
1/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Skin and subcutaneous tissue disorders
Rash Pruritic
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
5.0%
1/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic Dermatitis
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
7.1%
1/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Skin and subcutaneous tissue disorders
Skin Fissures
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
7.1%
1/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Vascular disorders
Aortic Aneurysm
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
3.3%
1/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Vascular disorders
Haematoma
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
3.3%
1/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Vascular disorders
Hot Flush
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
5.0%
1/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
3.3%
1/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Vascular disorders
Hypertension
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
6.7%
1/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
|
Vascular disorders
Phlebitis
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/20 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/8 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/14 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
0.00%
0/15 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
25.0%
1/4 • Up to 43 weeks
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.
- Publication restrictions are in place
Restriction type: OTHER