Trial Outcomes & Findings for Efficacy and Safety of Oral Regimens for the Treatment of Chronic HCV Infection (NCT NCT02202980)
NCT ID: NCT02202980
Last Updated: 2018-11-16
Results Overview
SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
273 participants
Primary outcome timeframe
Posttreatment Week 12
Results posted on
2018-11-16
Participant Flow
Participants were enrolled at study sites in New Zealand. The first participant was screened on 04 August 2014. The last study visit occurred on 09 May 2016.
349 participants were screened.
Participant milestones
| Measure |
LDV/SOF+RBV 24 Weeks (Cohort 1 Group 1)
Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) + ribavirin (RBV) (1000 or 1200 mg daily based on weight) for 24 weeks in participants who previously received LDV/SOF+RBV for ≥ 12 weeks without achieving sustained virologic response at 12 weeks following treatment (SVR12)
|
LDV/SOF 12 Weeks GT2 (Cohort 2 Group 1)
LDV/SOF (90/400 mg) for 12 weeks in participants with genotype 2 HCV infection
|
LDV/SOF 8 Weeks GT2 (Cohort 2 Group 2)
LDV/SOF (90/400 mg) for 8 weeks in participants with genotype 2 HCV infection
|
LDV/SOF 12 Weeks GT1/GT2/GT4 (Cohort 3 Group 1)
LDV/SOF (90/400 mg) for 12 weeks in participants with genotypes 1, 2, or 4 HCV infection and extrahepatic manifestations of chronic HCV infection
|
LDV/SOF 12 Weeks GT3 (Cohort 3 Group 2)
LDV/SOF (90/400 mg) + RBV (1000 or 1200 mg daily based on weight) for 12 weeks in participants with genotype 3 HCV infection and extrahepatic manifestations of chronic HCV infection
|
SOF/VEL+VOX 6 Weeks GT1 (Cohort 4)
Voxilaprevir (VOX) 100 mg with food on Day 1, followed by sofosbuvir/velpatasvir (SOF/VEL) (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in treatment-naive participants with genotype 1 HCV infection without cirrhosis
|
SOF/VEL+VOX 4 Weeks GT1 (Cohort 5 Group 1)
SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 4 weeks in treatment-naive participants with genotype 1 HCV infection without cirrhosis
|
SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 2)
SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in treatment-naive participants with genotype 1 HCV infection with cirrhosis
|
SOF/VEL+VOX 6 Weeks GT3 (Cohort 5 Group 3)
SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in treatment-naive participants with genotype 3 HCV infection with cirrhosis
|
SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 4)
SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in treatment-experienced participants with genotype 1 HCV infection with cirrhosis
|
SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 5)
SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in treatment-experienced participants with genotype 3 HCV infection with cirrhosis
|
SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 6)
SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in nonstructural protein (NS3/4A) protease inhibitor (PI)-treatment-experienced participants with genotype 1 HCV infection with or without cirrhosis
|
SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 7)
SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in direct-acting antiviral (DAA)-treatment-experienced participants with genotype 1 HCV infection with or without cirrhosis
|
SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 8)
SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in DAA-treatment-experienced participants with genotype 3 HCV infection with or without cirrhosis
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
14
|
26
|
27
|
32
|
13
|
15
|
15
|
15
|
18
|
17
|
19
|
28
|
30
|
4
|
|
Overall Study
COMPLETED
|
13
|
24
|
17
|
28
|
7
|
14
|
4
|
12
|
14
|
17
|
19
|
25
|
19
|
4
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
10
|
4
|
6
|
1
|
11
|
3
|
4
|
0
|
0
|
3
|
11
|
0
|
Reasons for withdrawal
| Measure |
LDV/SOF+RBV 24 Weeks (Cohort 1 Group 1)
Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) + ribavirin (RBV) (1000 or 1200 mg daily based on weight) for 24 weeks in participants who previously received LDV/SOF+RBV for ≥ 12 weeks without achieving sustained virologic response at 12 weeks following treatment (SVR12)
|
LDV/SOF 12 Weeks GT2 (Cohort 2 Group 1)
LDV/SOF (90/400 mg) for 12 weeks in participants with genotype 2 HCV infection
|
LDV/SOF 8 Weeks GT2 (Cohort 2 Group 2)
LDV/SOF (90/400 mg) for 8 weeks in participants with genotype 2 HCV infection
|
LDV/SOF 12 Weeks GT1/GT2/GT4 (Cohort 3 Group 1)
LDV/SOF (90/400 mg) for 12 weeks in participants with genotypes 1, 2, or 4 HCV infection and extrahepatic manifestations of chronic HCV infection
|
LDV/SOF 12 Weeks GT3 (Cohort 3 Group 2)
LDV/SOF (90/400 mg) + RBV (1000 or 1200 mg daily based on weight) for 12 weeks in participants with genotype 3 HCV infection and extrahepatic manifestations of chronic HCV infection
|
SOF/VEL+VOX 6 Weeks GT1 (Cohort 4)
Voxilaprevir (VOX) 100 mg with food on Day 1, followed by sofosbuvir/velpatasvir (SOF/VEL) (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in treatment-naive participants with genotype 1 HCV infection without cirrhosis
|
SOF/VEL+VOX 4 Weeks GT1 (Cohort 5 Group 1)
SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 4 weeks in treatment-naive participants with genotype 1 HCV infection without cirrhosis
|
SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 2)
SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in treatment-naive participants with genotype 1 HCV infection with cirrhosis
|
SOF/VEL+VOX 6 Weeks GT3 (Cohort 5 Group 3)
SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in treatment-naive participants with genotype 3 HCV infection with cirrhosis
|
SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 4)
SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in treatment-experienced participants with genotype 1 HCV infection with cirrhosis
|
SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 5)
SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in treatment-experienced participants with genotype 3 HCV infection with cirrhosis
|
SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 6)
SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in nonstructural protein (NS3/4A) protease inhibitor (PI)-treatment-experienced participants with genotype 1 HCV infection with or without cirrhosis
|
SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 7)
SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in direct-acting antiviral (DAA)-treatment-experienced participants with genotype 1 HCV infection with or without cirrhosis
|
SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 8)
SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in DAA-treatment-experienced participants with genotype 3 HCV infection with or without cirrhosis
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Lack of Efficacy
|
1
|
0
|
7
|
0
|
3
|
1
|
11
|
2
|
2
|
0
|
0
|
3
|
10
|
0
|
|
Overall Study
Protocol Violation
|
0
|
0
|
0
|
3
|
3
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
1
|
1
|
0
|
0
|
0
|
1
|
1
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Withdrew Consent
|
0
|
1
|
2
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Efficacy and Safety of Oral Regimens for the Treatment of Chronic HCV Infection
Baseline characteristics by cohort
| Measure |
LDV/SOF+RBV 24 Weeks (Cohort 1 Group 1)
n=14 Participants
LDV/SOF (90/400 mg) + RBV (1000 or 1200 mg daily based on weight) for 24 weeks in participants who previously received LDV/SOF+RBV for ≥ 12 weeks without achieving SVR12
|
LDV/SOF 12 Weeks GT2 (Cohort 2 Group 1)
n=26 Participants
LDV/SOF (90/400 mg) for 12 weeks in participants with genotype 2 HCV infection
|
LDV/SOF 8 Weeks GT2 (Cohort 2 Group 2)
n=27 Participants
LDV/SOF (90/400 mg) for 8 weeks in participants with genotype 2 HCV infection
|
LDV/SOF 12 Weeks GT1/GT2/GT4 (Cohort 3 Group 1)
n=32 Participants
LDV/SOF (90/400 mg) for 12 weeks in participants with genotypes 1, 2, or 4 HCV infection and extrahepatic manifestations of chronic HCV infection
|
LDV/SOF 12 Weeks GT3 (Cohort 3 Group 2)
n=13 Participants
LDV/SOF (90/400 mg) + RBV (1000 or 1200 mg daily based on weight) for 12 weeks in participants with genotype 3 HCV infection and extrahepatic manifestations of chronic HCV infection
|
SOF/VEL+VOX 6 Weeks GT1 (Cohort 4)
n=15 Participants
VOX 100 mg with food on Day 1, followed by SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in treatment-naive participants with genotype 1 HCV infection without cirrhosis
|
SOF/VEL+VOX 4 Weeks GT1 (Cohort 5 Group 1)
n=15 Participants
SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 4 weeks in treatment-naive participants with genotype 1 HCV infection without cirrhosis
|
SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 2)
n=15 Participants
SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in treatment-naive participants with genotype 1 HCV infection with cirrhosis
|
SOF/VEL+VOX 6 Weeks GT3 (Cohort 5 Group 3)
n=18 Participants
SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in treatment-naive participants with genotype 3 HCV infection with cirrhosis
|
SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 4)
n=17 Participants
SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in treatment-experienced participants with genotype 1 HCV infection with cirrhosis
|
SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 5)
n=19 Participants
SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in treatment-experienced participants with genotype 3 HCV infection with cirrhosis
|
SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 6)
n=28 Participants
SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in NS3/4A PI-treatment-experienced participants with genotype 1 HCV infection with or without cirrhosis
|
SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 7)
n=30 Participants
SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in DAA-treatment-experienced participants with genotype 1 HCV infection with or without cirrhosis
|
SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 8)
n=4 Participants
SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in DAA-treatment-experienced participants with genotype 3 HCV infection with or without cirrhosis
|
Total
n=273 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=3 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
29 Participants
n=7 Participants
|
13 Participants
n=31 Participants
|
13 Participants
n=30 Participants
|
15 Participants
n=3 Participants
|
14 Participants
n=6 Participants
|
18 Participants
n=114 Participants
|
16 Participants
|
18 Participants
n=19 Participants
|
26 Participants
n=4 Participants
|
29 Participants
n=7 Participants
|
4 Participants
n=7 Participants
|
257 Participants
n=3 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
1 Participants
|
1 Participants
n=19 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
16 Participants
n=3 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
12 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
8 Participants
n=30 Participants
|
6 Participants
n=3 Participants
|
4 Participants
n=6 Participants
|
8 Participants
n=114 Participants
|
3 Participants
|
4 Participants
n=19 Participants
|
9 Participants
n=4 Participants
|
6 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
82 Participants
n=3 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
20 Participants
n=7 Participants
|
12 Participants
n=31 Participants
|
7 Participants
n=30 Participants
|
9 Participants
n=3 Participants
|
11 Participants
n=6 Participants
|
10 Participants
n=114 Participants
|
14 Participants
|
15 Participants
n=19 Participants
|
19 Participants
n=4 Participants
|
24 Participants
n=7 Participants
|
4 Participants
n=7 Participants
|
191 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
27 Participants
n=206 Participants
|
32 Participants
n=7 Participants
|
13 Participants
n=31 Participants
|
15 Participants
n=30 Participants
|
14 Participants
n=3 Participants
|
15 Participants
n=6 Participants
|
18 Participants
n=114 Participants
|
17 Participants
|
19 Participants
n=19 Participants
|
28 Participants
n=4 Participants
|
30 Participants
n=7 Participants
|
4 Participants
n=7 Participants
|
272 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=3 Participants
|
|
Race/Ethnicity, Customized
White
|
10 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
26 Participants
n=7 Participants
|
12 Participants
n=31 Participants
|
14 Participants
n=30 Participants
|
12 Participants
n=3 Participants
|
14 Participants
n=6 Participants
|
12 Participants
n=114 Participants
|
16 Participants
|
18 Participants
n=19 Participants
|
24 Participants
n=4 Participants
|
27 Participants
n=7 Participants
|
3 Participants
n=7 Participants
|
233 Participants
n=3 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
2 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
16 Participants
n=3 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
3 Participants
n=114 Participants
|
1 Participants
|
1 Participants
n=19 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
15 Participants
n=3 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
3 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=7 Participants
|
9 Participants
n=3 Participants
|
|
HCV genotype
Genotype 1a
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
28 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
11 Participants
n=30 Participants
|
11 Participants
n=3 Participants
|
14 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
15 Participants
|
0 Participants
n=19 Participants
|
24 Participants
n=4 Participants
|
23 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
127 Participants
n=3 Participants
|
|
HCV genotype
Genotype 1b
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
4 Participants
n=30 Participants
|
4 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
2 Participants
|
0 Participants
n=19 Participants
|
4 Participants
n=4 Participants
|
7 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
25 Participants
n=3 Participants
|
|
HCV genotype
Genotype 2
|
7 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
27 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
36 Participants
n=3 Participants
|
|
HCV genotype
Genotype 2a or 2c
|
0 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
8 Participants
n=3 Participants
|
|
HCV genotype
Genotype 2b
|
0 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
16 Participants
n=3 Participants
|
|
HCV genotype
Genotype 3
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
12 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
17 Participants
n=114 Participants
|
0 Participants
|
19 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=7 Participants
|
54 Participants
n=3 Participants
|
|
HCV genotype
Genotype 3a
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=3 Participants
|
|
HCV genotype
Genotype 4
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=3 Participants
|
|
HCV genotype
Indeterminate
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=3 Participants
|
|
Cirrhosis Status
Yes
|
4 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
9 Participants
n=7 Participants
|
10 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
15 Participants
n=6 Participants
|
18 Participants
n=114 Participants
|
17 Participants
|
19 Participants
n=19 Participants
|
11 Participants
n=4 Participants
|
5 Participants
n=7 Participants
|
2 Participants
n=7 Participants
|
112 Participants
n=3 Participants
|
|
Cirrhosis Status
No
|
10 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
27 Participants
n=206 Participants
|
23 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
15 Participants
n=30 Participants
|
15 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
17 Participants
n=4 Participants
|
25 Participants
n=7 Participants
|
2 Participants
n=7 Participants
|
161 Participants
n=3 Participants
|
|
IL28b Status
CC
|
7 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
4 Participants
n=31 Participants
|
5 Participants
n=30 Participants
|
5 Participants
n=3 Participants
|
8 Participants
n=6 Participants
|
10 Participants
n=114 Participants
|
6 Participants
|
8 Participants
n=19 Participants
|
4 Participants
n=4 Participants
|
6 Participants
n=7 Participants
|
3 Participants
n=7 Participants
|
96 Participants
n=3 Participants
|
|
IL28b Status
CT
|
7 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
18 Participants
n=7 Participants
|
6 Participants
n=31 Participants
|
8 Participants
n=30 Participants
|
10 Participants
n=3 Participants
|
7 Participants
n=6 Participants
|
6 Participants
n=114 Participants
|
9 Participants
|
9 Participants
n=19 Participants
|
21 Participants
n=4 Participants
|
18 Participants
n=7 Participants
|
1 Participants
n=7 Participants
|
145 Participants
n=3 Participants
|
|
IL28b Status
TT
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
2 Participants
n=114 Participants
|
2 Participants
|
2 Participants
n=19 Participants
|
3 Participants
n=4 Participants
|
6 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
31 Participants
n=3 Participants
|
|
HCV RNA Category
< 800,000 IU/mL
|
1 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
8 Participants
n=7 Participants
|
4 Participants
n=31 Participants
|
5 Participants
n=30 Participants
|
4 Participants
n=3 Participants
|
4 Participants
n=6 Participants
|
5 Participants
n=114 Participants
|
3 Participants
|
3 Participants
n=19 Participants
|
10 Participants
n=4 Participants
|
5 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
68 Participants
n=3 Participants
|
|
HCV RNA Category
≥ 800,000 IU/mL
|
13 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
24 Participants
n=7 Participants
|
9 Participants
n=31 Participants
|
10 Participants
n=30 Participants
|
11 Participants
n=3 Participants
|
11 Participants
n=6 Participants
|
13 Participants
n=114 Participants
|
14 Participants
|
16 Participants
n=19 Participants
|
18 Participants
n=4 Participants
|
25 Participants
n=7 Participants
|
4 Participants
n=7 Participants
|
205 Participants
n=3 Participants
|
|
Prior HCV Treatment
Treatment-Naive
|
0 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
17 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
15 Participants
n=30 Participants
|
15 Participants
n=3 Participants
|
15 Participants
n=6 Participants
|
18 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
124 Participants
n=3 Participants
|
|
Prior HCV Treatment
Treatment-Experienced
|
14 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
15 Participants
n=7 Participants
|
10 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
17 Participants
|
19 Participants
n=19 Participants
|
28 Participants
n=4 Participants
|
30 Participants
n=7 Participants
|
4 Participants
n=7 Participants
|
149 Participants
n=3 Participants
|
PRIMARY outcome
Timeframe: Posttreatment Week 12Population: Full Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.
Outcome measures
| Measure |
LDV/SOF+RBV 24 Weeks (Cohort 1 Group 1)
n=14 Participants
LDV/SOF (90/400 mg) + RBV (1000 or 1200 mg daily based on weight) for 24 weeks in participants who previously received LDV/SOF+RBV for ≥ 12 weeks without achieving SVR12
|
LDV/SOF 12 Weeks GT2 (Cohort 2 Group 1)
n=26 Participants
LDV/SOF (90/400 mg) for 12 weeks in participants with genotype 2 HCV infection
|
LDV/SOF 8 Weeks GT2 (Cohort 2 Group 2)
n=27 Participants
LDV/SOF (90/400 mg) for 8 weeks in participants with genotype 2 HCV infection
|
LDV/SOF 12 Weeks GT1/GT2/GT4 (Cohort 3 Group 1)
n=32 Participants
LDV/SOF (90/400 mg) for 12 weeks in participants with genotypes 1, 2, or 4 HCV infection and extrahepatic manifestations of chronic HCV infection
|
LDV/SOF 12 Weeks GT3 (Cohort 3 Group 2)
n=13 Participants
LDV/SOF (90/400 mg) + RBV (1000 or 1200 mg daily based on weight) for 12 weeks in participants with genotype 3 HCV infection and extrahepatic manifestations of chronic HCV infection
|
SOF/VEL+VOX 6 Weeks GT1 (Cohort 4)
n=15 Participants
VOX 100 mg with food on Day 1, followed by SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in treatment-naive participants with genotype 1 HCV infection without cirrhosis
|
SOF/VEL+VOX 4 Weeks GT1 (Cohort 5 Group 1)
n=15 Participants
SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 4 weeks in treatment-naive participants with genotype 1 HCV infection without cirrhosis
|
SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 2)
n=15 Participants
SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in treatment-naive participants with genotype 1 HCV infection with cirrhosis
|
SOF/VEL+VOX 6 Weeks GT3 (Cohort 5 Group 3)
n=18 Participants
SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in treatment-naive participants with genotype 3 HCV infection with cirrhosis
|
SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 4)
n=17 Participants
SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in treatment-experienced participants with genotype 1 HCV infection with cirrhosis
|
SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 5)
n=19 Participants
SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in treatment-experienced participants with genotype 3 HCV infection with cirrhosis
|
SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 6)
n=28 Participants
SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in NS3/4A PI-treatment-experienced participants with genotype 1 HCV infection with or without cirrhosis
|
SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 7)
n=30 Participants
SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in DAA-treatment-experienced participants with genotype 1 HCV infection with or without cirrhosis
|
SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 8)
n=4 Participants
SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in DAA-treatment-experienced participants with genotype 3 HCV infection with or without cirrhosis
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
|
92.9 percentage of participants
Interval 66.1 to 99.8
|
96.2 percentage of participants
Interval 80.4 to 99.9
|
74.1 percentage of participants
Interval 53.7 to 88.9
|
100.0 percentage of participants
Interval 89.1 to 100.0
|
76.9 percentage of participants
Interval 46.2 to 95.0
|
93.3 percentage of participants
Interval 68.1 to 99.8
|
26.7 percentage of participants
Interval 7.8 to 55.1
|
86.7 percentage of participants
Interval 59.5 to 98.3
|
83.3 percentage of participants
Interval 58.6 to 96.4
|
100.0 percentage of participants
Interval 80.5 to 100.0
|
100.0 percentage of participants
Interval 82.4 to 100.0
|
89.3 percentage of participants
Interval 71.8 to 97.7
|
66.7 percentage of participants
Interval 47.2 to 82.7
|
100.0 percentage of participants
Interval 39.8 to 100.0
|
PRIMARY outcome
Timeframe: Up to 24 weeksPopulation: Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
Outcome measures
| Measure |
LDV/SOF+RBV 24 Weeks (Cohort 1 Group 1)
n=14 Participants
LDV/SOF (90/400 mg) + RBV (1000 or 1200 mg daily based on weight) for 24 weeks in participants who previously received LDV/SOF+RBV for ≥ 12 weeks without achieving SVR12
|
LDV/SOF 12 Weeks GT2 (Cohort 2 Group 1)
n=26 Participants
LDV/SOF (90/400 mg) for 12 weeks in participants with genotype 2 HCV infection
|
LDV/SOF 8 Weeks GT2 (Cohort 2 Group 2)
n=27 Participants
LDV/SOF (90/400 mg) for 8 weeks in participants with genotype 2 HCV infection
|
LDV/SOF 12 Weeks GT1/GT2/GT4 (Cohort 3 Group 1)
n=32 Participants
LDV/SOF (90/400 mg) for 12 weeks in participants with genotypes 1, 2, or 4 HCV infection and extrahepatic manifestations of chronic HCV infection
|
LDV/SOF 12 Weeks GT3 (Cohort 3 Group 2)
n=13 Participants
LDV/SOF (90/400 mg) + RBV (1000 or 1200 mg daily based on weight) for 12 weeks in participants with genotype 3 HCV infection and extrahepatic manifestations of chronic HCV infection
|
SOF/VEL+VOX 6 Weeks GT1 (Cohort 4)
n=15 Participants
VOX 100 mg with food on Day 1, followed by SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in treatment-naive participants with genotype 1 HCV infection without cirrhosis
|
SOF/VEL+VOX 4 Weeks GT1 (Cohort 5 Group 1)
n=15 Participants
SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 4 weeks in treatment-naive participants with genotype 1 HCV infection without cirrhosis
|
SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 2)
n=15 Participants
SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in treatment-naive participants with genotype 1 HCV infection with cirrhosis
|
SOF/VEL+VOX 6 Weeks GT3 (Cohort 5 Group 3)
n=18 Participants
SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in treatment-naive participants with genotype 3 HCV infection with cirrhosis
|
SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 4)
n=17 Participants
SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in treatment-experienced participants with genotype 1 HCV infection with cirrhosis
|
SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 5)
n=19 Participants
SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in treatment-experienced participants with genotype 3 HCV infection with cirrhosis
|
SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 6)
n=28 Participants
SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in NS3/4A PI-treatment-experienced participants with genotype 1 HCV infection with or without cirrhosis
|
SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 7)
n=30 Participants
SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in DAA-treatment-experienced participants with genotype 1 HCV infection with or without cirrhosis
|
SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 8)
n=4 Participants
SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in DAA-treatment-experienced participants with genotype 3 HCV infection with or without cirrhosis
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
|
7.1 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
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Posttreatment Weeks 4 and 24Population: Full Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
SVR4 and SVR 24 were defined as HCV RNA \< LLOQ at 4 and 24 weeks after stopping study treatment, respectively.
Outcome measures
| Measure |
LDV/SOF+RBV 24 Weeks (Cohort 1 Group 1)
n=14 Participants
LDV/SOF (90/400 mg) + RBV (1000 or 1200 mg daily based on weight) for 24 weeks in participants who previously received LDV/SOF+RBV for ≥ 12 weeks without achieving SVR12
|
LDV/SOF 12 Weeks GT2 (Cohort 2 Group 1)
n=26 Participants
LDV/SOF (90/400 mg) for 12 weeks in participants with genotype 2 HCV infection
|
LDV/SOF 8 Weeks GT2 (Cohort 2 Group 2)
n=27 Participants
LDV/SOF (90/400 mg) for 8 weeks in participants with genotype 2 HCV infection
|
LDV/SOF 12 Weeks GT1/GT2/GT4 (Cohort 3 Group 1)
n=32 Participants
LDV/SOF (90/400 mg) for 12 weeks in participants with genotypes 1, 2, or 4 HCV infection and extrahepatic manifestations of chronic HCV infection
|
LDV/SOF 12 Weeks GT3 (Cohort 3 Group 2)
n=13 Participants
LDV/SOF (90/400 mg) + RBV (1000 or 1200 mg daily based on weight) for 12 weeks in participants with genotype 3 HCV infection and extrahepatic manifestations of chronic HCV infection
|
SOF/VEL+VOX 6 Weeks GT1 (Cohort 4)
n=15 Participants
VOX 100 mg with food on Day 1, followed by SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in treatment-naive participants with genotype 1 HCV infection without cirrhosis
|
SOF/VEL+VOX 4 Weeks GT1 (Cohort 5 Group 1)
n=15 Participants
SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 4 weeks in treatment-naive participants with genotype 1 HCV infection without cirrhosis
|
SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 2)
n=15 Participants
SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in treatment-naive participants with genotype 1 HCV infection with cirrhosis
|
SOF/VEL+VOX 6 Weeks GT3 (Cohort 5 Group 3)
n=18 Participants
SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in treatment-naive participants with genotype 3 HCV infection with cirrhosis
|
SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 4)
n=17 Participants
SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in treatment-experienced participants with genotype 1 HCV infection with cirrhosis
|
SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 5)
n=19 Participants
SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in treatment-experienced participants with genotype 3 HCV infection with cirrhosis
|
SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 6)
n=28 Participants
SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in NS3/4A PI-treatment-experienced participants with genotype 1 HCV infection with or without cirrhosis
|
SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 7)
n=30 Participants
SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in DAA-treatment-experienced participants with genotype 1 HCV infection with or without cirrhosis
|
SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 8)
n=4 Participants
SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in DAA-treatment-experienced participants with genotype 3 HCV infection with or without cirrhosis
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
SVR4
|
92.9 percentage of participants
Interval 66.1 to 99.8
|
96.2 percentage of participants
Interval 80.4 to 99.9
|
81.5 percentage of participants
Interval 61.9 to 93.7
|
100.0 percentage of participants
Interval 89.1 to 100.0
|
76.9 percentage of participants
Interval 46.2 to 95.0
|
100.0 percentage of participants
Interval 78.2 to 100.0
|
73.3 percentage of participants
Interval 44.9 to 92.2
|
86.7 percentage of participants
Interval 59.5 to 98.3
|
88.9 percentage of participants
Interval 65.3 to 98.6
|
100.0 percentage of participants
Interval 80.5 to 100.0
|
100.0 percentage of participants
Interval 82.4 to 100.0
|
92.9 percentage of participants
Interval 76.5 to 99.1
|
86.7 percentage of participants
Interval 69.3 to 96.2
|
100.0 percentage of participants
Interval 39.8 to 100.0
|
|
Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
SVR24
|
92.9 percentage of participants
Interval 66.1 to 99.8
|
96.2 percentage of participants
Interval 80.4 to 99.9
|
74.1 percentage of participants
Interval 53.7 to 88.9
|
100.0 percentage of participants
Interval 89.1 to 100.0
|
76.9 percentage of participants
Interval 46.2 to 95.0
|
93.3 percentage of participants
Interval 68.1 to 99.8
|
20.0 percentage of participants
Interval 4.3 to 48.1
|
86.7 percentage of participants
Interval 59.5 to 98.3
|
83.3 percentage of participants
Interval 58.6 to 96.4
|
100.0 percentage of participants
Interval 80.5 to 100.0
|
100.0 percentage of participants
Interval 82.4 to 100.0
|
89.3 percentage of participants
Interval 71.8 to 97.7
|
66.7 percentage of participants
Interval 47.2 to 82.7
|
100.0 percentage of participants
Interval 39.8 to 100.0
|
SECONDARY outcome
Timeframe: Up to Posttreatment Week 24Population: Full Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
Virologic failure was defined as: * On-treatment virologic failure: * Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA \< LLOQ while on treatment), or * Rebound (confirmed \> 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or * Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment) * Virologic relapse: * Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA \< LLOQ at last on-treatment visit.
Outcome measures
| Measure |
LDV/SOF+RBV 24 Weeks (Cohort 1 Group 1)
n=14 Participants
LDV/SOF (90/400 mg) + RBV (1000 or 1200 mg daily based on weight) for 24 weeks in participants who previously received LDV/SOF+RBV for ≥ 12 weeks without achieving SVR12
|
LDV/SOF 12 Weeks GT2 (Cohort 2 Group 1)
n=26 Participants
LDV/SOF (90/400 mg) for 12 weeks in participants with genotype 2 HCV infection
|
LDV/SOF 8 Weeks GT2 (Cohort 2 Group 2)
n=27 Participants
LDV/SOF (90/400 mg) for 8 weeks in participants with genotype 2 HCV infection
|
LDV/SOF 12 Weeks GT1/GT2/GT4 (Cohort 3 Group 1)
n=32 Participants
LDV/SOF (90/400 mg) for 12 weeks in participants with genotypes 1, 2, or 4 HCV infection and extrahepatic manifestations of chronic HCV infection
|
LDV/SOF 12 Weeks GT3 (Cohort 3 Group 2)
n=13 Participants
LDV/SOF (90/400 mg) + RBV (1000 or 1200 mg daily based on weight) for 12 weeks in participants with genotype 3 HCV infection and extrahepatic manifestations of chronic HCV infection
|
SOF/VEL+VOX 6 Weeks GT1 (Cohort 4)
n=15 Participants
VOX 100 mg with food on Day 1, followed by SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in treatment-naive participants with genotype 1 HCV infection without cirrhosis
|
SOF/VEL+VOX 4 Weeks GT1 (Cohort 5 Group 1)
n=15 Participants
SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 4 weeks in treatment-naive participants with genotype 1 HCV infection without cirrhosis
|
SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 2)
n=15 Participants
SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in treatment-naive participants with genotype 1 HCV infection with cirrhosis
|
SOF/VEL+VOX 6 Weeks GT3 (Cohort 5 Group 3)
n=18 Participants
SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in treatment-naive participants with genotype 3 HCV infection with cirrhosis
|
SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 4)
n=17 Participants
SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in treatment-experienced participants with genotype 1 HCV infection with cirrhosis
|
SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 5)
n=19 Participants
SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in treatment-experienced participants with genotype 3 HCV infection with cirrhosis
|
SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 6)
n=28 Participants
SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in NS3/4A PI-treatment-experienced participants with genotype 1 HCV infection with or without cirrhosis
|
SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 7)
n=30 Participants
SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in DAA-treatment-experienced participants with genotype 1 HCV infection with or without cirrhosis
|
SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 8)
n=4 Participants
SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in DAA-treatment-experienced participants with genotype 3 HCV infection with or without cirrhosis
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Virologic Failure
|
7.1 percentage of participants
|
0 percentage of participants
|
22.2 percentage of participants
|
0 percentage of participants
|
23.1 percentage of participants
|
6.7 percentage of participants
|
73.3 percentage of participants
|
13.3 percentage of participants
|
11.1 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
10.7 percentage of participants
|
30.0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Weeks 1, 2, 4, 6, 8, 12, 16, 20, and 24 (depending on treatment duration; Week 6 data was not collected for Cohorts 1-3)Population: Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
LDV/SOF+RBV 24 Weeks (Cohort 1 Group 1)
n=14 Participants
LDV/SOF (90/400 mg) + RBV (1000 or 1200 mg daily based on weight) for 24 weeks in participants who previously received LDV/SOF+RBV for ≥ 12 weeks without achieving SVR12
|
LDV/SOF 12 Weeks GT2 (Cohort 2 Group 1)
n=25 Participants
LDV/SOF (90/400 mg) for 12 weeks in participants with genotype 2 HCV infection
|
LDV/SOF 8 Weeks GT2 (Cohort 2 Group 2)
n=27 Participants
LDV/SOF (90/400 mg) for 8 weeks in participants with genotype 2 HCV infection
|
LDV/SOF 12 Weeks GT1/GT2/GT4 (Cohort 3 Group 1)
n=32 Participants
LDV/SOF (90/400 mg) for 12 weeks in participants with genotypes 1, 2, or 4 HCV infection and extrahepatic manifestations of chronic HCV infection
|
LDV/SOF 12 Weeks GT3 (Cohort 3 Group 2)
n=13 Participants
LDV/SOF (90/400 mg) + RBV (1000 or 1200 mg daily based on weight) for 12 weeks in participants with genotype 3 HCV infection and extrahepatic manifestations of chronic HCV infection
|
SOF/VEL+VOX 6 Weeks GT1 (Cohort 4)
n=15 Participants
VOX 100 mg with food on Day 1, followed by SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in treatment-naive participants with genotype 1 HCV infection without cirrhosis
|
SOF/VEL+VOX 4 Weeks GT1 (Cohort 5 Group 1)
n=15 Participants
SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 4 weeks in treatment-naive participants with genotype 1 HCV infection without cirrhosis
|
SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 2)
n=15 Participants
SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in treatment-naive participants with genotype 1 HCV infection with cirrhosis
|
SOF/VEL+VOX 6 Weeks GT3 (Cohort 5 Group 3)
n=18 Participants
SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in treatment-naive participants with genotype 3 HCV infection with cirrhosis
|
SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 4)
n=17 Participants
SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in treatment-experienced participants with genotype 1 HCV infection with cirrhosis
|
SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 5)
n=19 Participants
SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in treatment-experienced participants with genotype 3 HCV infection with cirrhosis
|
SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 6)
n=28 Participants
SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in NS3/4A PI-treatment-experienced participants with genotype 1 HCV infection with or without cirrhosis
|
SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 7)
n=30 Participants
SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in DAA-treatment-experienced participants with genotype 1 HCV infection with or without cirrhosis
|
SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 8)
n=4 Participants
SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in DAA-treatment-experienced participants with genotype 3 HCV infection with or without cirrhosis
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With HCV RNA < LLOQ While on Treatment by Study Visit
Week 1
|
7.1 percentage of participants
|
28.0 percentage of participants
|
7.4 percentage of participants
|
9.4 percentage of participants
|
7.7 percentage of participants
|
26.7 percentage of participants
|
26.7 percentage of participants
|
26.7 percentage of participants
|
16.7 percentage of participants
|
5.9 percentage of participants
|
5.3 percentage of participants
|
7.1 percentage of participants
|
13.3 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With HCV RNA < LLOQ While on Treatment by Study Visit
Week 4
|
100.0 percentage of participants
|
92.0 percentage of participants
|
92.6 percentage of participants
|
87.5 percentage of participants
|
84.6 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
76.5 percentage of participants
|
84.2 percentage of participants
|
85.7 percentage of participants
|
93.3 percentage of participants
|
100.0 percentage of participants
|
|
Percentage of Participants With HCV RNA < LLOQ While on Treatment by Study Visit
Week 12
|
100.0 percentage of participants
|
100.0 percentage of participants
|
—
|
100.0 percentage of participants
|
100.0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With HCV RNA < LLOQ While on Treatment by Study Visit
Week 2
|
64.3 percentage of participants
|
60.0 percentage of participants
|
40.7 percentage of participants
|
53.1 percentage of participants
|
7.7 percentage of participants
|
66.7 percentage of participants
|
53.3 percentage of participants
|
66.7 percentage of participants
|
88.9 percentage of participants
|
41.2 percentage of participants
|
42.1 percentage of participants
|
60.7 percentage of participants
|
43.3 percentage of participants
|
25.0 percentage of participants
|
|
Percentage of Participants With HCV RNA < LLOQ While on Treatment by Study Visit
Week 6
|
—
|
—
|
—
|
—
|
—
|
100.0 percentage of participants
|
—
|
100.0 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
94.7 percentage of participants
|
96.4 percentage of participants
|
96.7 percentage of participants
|
100.0 percentage of participants
|
|
Percentage of Participants With HCV RNA < LLOQ While on Treatment by Study Visit
Week 8
|
100.0 percentage of participants
|
100.0 percentage of participants
|
96.3 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
—
|
—
|
—
|
—
|
100.0 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
—
|
100.0 percentage of participants
|
|
Percentage of Participants With HCV RNA < LLOQ While on Treatment by Study Visit
Week 16
|
92.9 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With HCV RNA < LLOQ While on Treatment by Study Visit
Week 20
|
92.9 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With HCV RNA < LLOQ While on Treatment by Study Visit
Week 24
|
100.0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
LDV/SOF+RBV 24 Weeks (Cohort 1 Group 1)
Serious events: 2 serious events
Other events: 12 other events
Deaths: 0 deaths
LDV/SOF 12 Weeks GT2 (Cohort 2 Group 1)
Serious events: 1 serious events
Other events: 15 other events
Deaths: 0 deaths
LDV/SOF 8 Weeks GT2 (Cohort 2 Group 2)
Serious events: 2 serious events
Other events: 21 other events
Deaths: 0 deaths
LDV/SOF 12 Weeks GT1/GT2/GT4 (Cohort 3 Group 1)
Serious events: 3 serious events
Other events: 24 other events
Deaths: 0 deaths
LDV/SOF 12 Weeks GT3 (Cohort 3 Group 2)
Serious events: 2 serious events
Other events: 11 other events
Deaths: 0 deaths
SOF/VEL+VOX 6 Weeks GT1 (Cohort 4)
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
SOF/VEL+VOX 4 Weeks GT1 (Cohort 5 Group 1)
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 2)
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
SOF/VEL+VOX 6 Weeks GT3 (Cohort 5 Group 3)
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 4)
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 5)
Serious events: 2 serious events
Other events: 14 other events
Deaths: 0 deaths
SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 6)
Serious events: 1 serious events
Other events: 21 other events
Deaths: 0 deaths
SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 7)
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 8)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
LDV/SOF+RBV 24 Weeks (Cohort 1 Group 1)
n=14 participants at risk
LDV/SOF (90/400 mg) + RBV (1000 or 1200 mg daily based on weight) for 24 weeks in participants who previously received LDV/SOF+RBV for ≥ 12 weeks without achieving SVR12
|
LDV/SOF 12 Weeks GT2 (Cohort 2 Group 1)
n=26 participants at risk
LDV/SOF (90/400 mg) for 12 weeks in participants with genotype 2 HCV infection
|
LDV/SOF 8 Weeks GT2 (Cohort 2 Group 2)
n=27 participants at risk
LDV/SOF (90/400 mg) for 8 weeks in participants with genotype 2 HCV infection
|
LDV/SOF 12 Weeks GT1/GT2/GT4 (Cohort 3 Group 1)
n=32 participants at risk
LDV/SOF (90/400 mg) for 12 weeks in participants with genotypes 1, 2, or 4 HCV infection and extrahepatic manifestations of chronic HCV infection
|
LDV/SOF 12 Weeks GT3 (Cohort 3 Group 2)
n=13 participants at risk
LDV/SOF (90/400 mg) + RBV (1000 or 1200 mg daily based on weight) for 12 weeks in participants with genotype 3 HCV infection and extrahepatic manifestations of chronic HCV infection
|
SOF/VEL+VOX 6 Weeks GT1 (Cohort 4)
n=15 participants at risk
VOX 100 mg with food on Day 1, followed by SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in treatment-naive participants with genotype 1 HCV infection without cirrhosis
|
SOF/VEL+VOX 4 Weeks GT1 (Cohort 5 Group 1)
n=15 participants at risk
SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 4 weeks in treatment-naive participants with genotype 1 HCV infection without cirrhosis
|
SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 2)
n=15 participants at risk
SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in treatment-naive participants with genotype 1 HCV infection with cirrhosis
|
SOF/VEL+VOX 6 Weeks GT3 (Cohort 5 Group 3)
n=18 participants at risk
SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in treatment-naive participants with genotype 3 HCV infection with cirrhosis
|
SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 4)
n=17 participants at risk
SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in treatment-experienced participants with genotype 1 HCV infection with cirrhosis
|
SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 5)
n=19 participants at risk
SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in treatment-experienced participants with genotype 3 HCV infection with cirrhosis
|
SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 6)
n=28 participants at risk
SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in NS3/4A PI-treatment-experienced participants with genotype 1 HCV infection with or without cirrhosis
|
SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 7)
n=30 participants at risk
SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in DAA-treatment-experienced participants with genotype 1 HCV infection with or without cirrhosis
|
SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 8)
n=4 participants at risk
SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in DAA-treatment-experienced participants with genotype 3 HCV infection with or without cirrhosis
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/14 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/26 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
3.7%
1/27 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/32 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/13 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/18 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/17 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
3.6%
1/28 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/30 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/4 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
|
Ear and labyrinth disorders
Meniere's disease
|
0.00%
0/14 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/26 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/27 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
3.1%
1/32 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/13 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/18 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/17 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/28 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/30 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/4 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/14 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
3.8%
1/26 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/27 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/32 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/13 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/18 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/17 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/28 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/30 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/4 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
|
Gastrointestinal disorders
Nausea
|
7.1%
1/14 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/26 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/27 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/32 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/13 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/18 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/17 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/28 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/30 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/4 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
|
Infections and infestations
Gastroenteritis
|
7.1%
1/14 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/26 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/27 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/32 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/13 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/18 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/17 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/28 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/30 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/4 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/14 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/26 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/27 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/32 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
7.7%
1/13 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/18 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/17 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/28 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/30 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/4 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
|
Infections and infestations
Pneumonia
|
0.00%
0/14 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/26 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/27 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
3.1%
1/32 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/13 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/18 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/17 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/28 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/30 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/4 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
|
Injury, poisoning and procedural complications
Fall
|
7.1%
1/14 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/26 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/27 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/32 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/13 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/18 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/17 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/28 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/30 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/4 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/14 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/26 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/27 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/32 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
7.7%
1/13 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/18 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/17 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/28 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/30 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/4 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma
|
0.00%
0/14 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/26 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/27 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/32 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/13 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/18 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/17 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
5.3%
1/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/28 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/30 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/4 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma
|
0.00%
0/14 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/26 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/27 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/32 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/13 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/18 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/17 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
5.3%
1/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/28 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/30 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/4 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
|
Psychiatric disorders
Bipolar I disorder
|
0.00%
0/14 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/26 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
3.7%
1/27 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/32 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/13 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/18 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/17 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/28 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/30 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/4 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/14 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/26 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/27 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/32 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
7.7%
1/13 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/18 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/17 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/28 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/30 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/4 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/14 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/26 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/27 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/32 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
7.7%
1/13 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/18 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/17 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/28 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/30 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/4 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/14 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/26 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/27 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
3.1%
1/32 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/13 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/18 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/17 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/28 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/30 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/4 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
Other adverse events
| Measure |
LDV/SOF+RBV 24 Weeks (Cohort 1 Group 1)
n=14 participants at risk
LDV/SOF (90/400 mg) + RBV (1000 or 1200 mg daily based on weight) for 24 weeks in participants who previously received LDV/SOF+RBV for ≥ 12 weeks without achieving SVR12
|
LDV/SOF 12 Weeks GT2 (Cohort 2 Group 1)
n=26 participants at risk
LDV/SOF (90/400 mg) for 12 weeks in participants with genotype 2 HCV infection
|
LDV/SOF 8 Weeks GT2 (Cohort 2 Group 2)
n=27 participants at risk
LDV/SOF (90/400 mg) for 8 weeks in participants with genotype 2 HCV infection
|
LDV/SOF 12 Weeks GT1/GT2/GT4 (Cohort 3 Group 1)
n=32 participants at risk
LDV/SOF (90/400 mg) for 12 weeks in participants with genotypes 1, 2, or 4 HCV infection and extrahepatic manifestations of chronic HCV infection
|
LDV/SOF 12 Weeks GT3 (Cohort 3 Group 2)
n=13 participants at risk
LDV/SOF (90/400 mg) + RBV (1000 or 1200 mg daily based on weight) for 12 weeks in participants with genotype 3 HCV infection and extrahepatic manifestations of chronic HCV infection
|
SOF/VEL+VOX 6 Weeks GT1 (Cohort 4)
n=15 participants at risk
VOX 100 mg with food on Day 1, followed by SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in treatment-naive participants with genotype 1 HCV infection without cirrhosis
|
SOF/VEL+VOX 4 Weeks GT1 (Cohort 5 Group 1)
n=15 participants at risk
SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 4 weeks in treatment-naive participants with genotype 1 HCV infection without cirrhosis
|
SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 2)
n=15 participants at risk
SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in treatment-naive participants with genotype 1 HCV infection with cirrhosis
|
SOF/VEL+VOX 6 Weeks GT3 (Cohort 5 Group 3)
n=18 participants at risk
SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in treatment-naive participants with genotype 3 HCV infection with cirrhosis
|
SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 4)
n=17 participants at risk
SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in treatment-experienced participants with genotype 1 HCV infection with cirrhosis
|
SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 5)
n=19 participants at risk
SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in treatment-experienced participants with genotype 3 HCV infection with cirrhosis
|
SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 6)
n=28 participants at risk
SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in NS3/4A PI-treatment-experienced participants with genotype 1 HCV infection with or without cirrhosis
|
SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 7)
n=30 participants at risk
SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in DAA-treatment-experienced participants with genotype 1 HCV infection with or without cirrhosis
|
SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 8)
n=4 participants at risk
SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in DAA-treatment-experienced participants with genotype 3 HCV infection with or without cirrhosis
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
General disorders
Vessel puncture site haematoma
|
0.00%
0/14 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/26 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/27 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/32 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/13 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
5.6%
1/18 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/17 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/28 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/30 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/4 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
|
Immune system disorders
Food allergy
|
0.00%
0/14 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/26 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/27 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/32 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/13 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
6.7%
1/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/18 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/17 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/28 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/30 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/4 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Sinus disorder
|
0.00%
0/14 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/26 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/27 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/32 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/13 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
5.6%
1/18 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/17 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/28 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/30 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/4 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/14 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/26 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/27 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/32 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/13 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/18 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/17 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/28 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/30 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
25.0%
1/4 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
7.1%
1/14 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
3.8%
1/26 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/27 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/32 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/13 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/18 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/17 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/28 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
3.3%
1/30 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/4 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/14 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/26 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/27 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/32 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
7.7%
1/13 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/18 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/17 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/28 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/30 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/4 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
|
Blood and lymphatic system disorders
Haemolytic anaemia
|
0.00%
0/14 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/26 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/27 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/32 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
15.4%
2/13 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/18 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/17 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/28 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/30 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/4 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
|
Cardiac disorders
Palpitations
|
0.00%
0/14 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/26 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/27 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/32 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
7.7%
1/13 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/18 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/17 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/28 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/30 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/4 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
|
Ear and labyrinth disorders
Deafness
|
0.00%
0/14 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/26 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/27 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/32 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/13 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
5.6%
1/18 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/17 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/28 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/30 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/4 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/14 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/26 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/27 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/32 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/13 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/18 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/17 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
5.3%
1/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/28 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/30 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/4 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/14 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/26 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/27 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/32 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/13 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
13.3%
2/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
5.6%
1/18 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/17 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/28 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/30 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/4 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
|
Eye disorders
Diplopia
|
7.1%
1/14 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/26 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/27 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/32 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/13 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/18 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/17 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/28 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/30 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/4 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
|
Eye disorders
Vision blurred
|
0.00%
0/14 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/26 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/27 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/32 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/13 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
6.7%
1/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/18 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/17 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
3.6%
1/28 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/30 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/4 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
|
Eye disorders
Visual impairment
|
0.00%
0/14 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/26 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/27 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/32 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/13 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
5.6%
1/18 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/17 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
5.3%
1/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/28 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/30 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/4 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
|
Eye disorders
Vitreous detachment
|
0.00%
0/14 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/26 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/27 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/32 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/13 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/18 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/17 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
5.3%
1/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/28 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/30 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/4 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/14 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
3.8%
1/26 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/27 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/32 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/13 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
6.7%
1/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
13.3%
2/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/18 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/17 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/28 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
3.3%
1/30 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/4 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/14 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
3.8%
1/26 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/27 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/32 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/13 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
6.7%
1/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/18 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/17 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/28 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
3.3%
1/30 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/4 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
|
Gastrointestinal disorders
Abdominal pain
|
7.1%
1/14 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/26 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/27 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
3.1%
1/32 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/13 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/18 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/17 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
7.1%
2/28 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
3.3%
1/30 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/4 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/14 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/26 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/27 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/32 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/13 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
5.6%
1/18 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/17 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/28 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/30 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/4 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/14 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/26 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
3.7%
1/27 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/32 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/13 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/18 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
5.9%
1/17 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/28 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/30 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/4 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
|
Gastrointestinal disorders
Constipation
|
7.1%
1/14 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/26 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/27 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
3.1%
1/32 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/13 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
6.7%
1/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
5.6%
1/18 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
11.8%
2/17 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/28 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/30 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/4 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/14 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
7.7%
2/26 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
3.7%
1/27 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
3.1%
1/32 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/13 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
20.0%
3/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
13.3%
2/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
22.2%
4/18 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
5.9%
1/17 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
21.4%
6/28 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
6.7%
2/30 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
50.0%
2/4 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/14 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/26 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
7.4%
2/27 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/32 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/13 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
5.6%
1/18 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
11.8%
2/17 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/28 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/30 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/4 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/14 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/26 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/27 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/32 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/13 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/18 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/17 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/28 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
3.3%
1/30 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
25.0%
1/4 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
7.1%
1/14 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/26 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/27 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/32 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/13 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
6.7%
1/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
5.6%
1/18 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/17 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
15.8%
3/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/28 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/30 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/4 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
|
Gastrointestinal disorders
Glossodynia
|
7.1%
1/14 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/26 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/27 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/32 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/13 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/18 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/17 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/28 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/30 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/4 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/14 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/26 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/27 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/32 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/13 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
13.3%
2/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/18 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/17 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/28 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
6.7%
2/30 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/4 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
|
Gastrointestinal disorders
Nausea
|
21.4%
3/14 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
15.4%
4/26 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
18.5%
5/27 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
15.6%
5/32 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
7.7%
1/13 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
33.3%
5/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
33.3%
5/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
20.0%
3/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
16.7%
3/18 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
5.9%
1/17 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
36.8%
7/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
10.7%
3/28 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
16.7%
5/30 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
25.0%
1/4 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
|
Gastrointestinal disorders
Retching
|
0.00%
0/14 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/26 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/27 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/32 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/13 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
5.6%
1/18 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/17 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/28 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/30 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/4 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
|
Gastrointestinal disorders
Salivary gland enlargement
|
0.00%
0/14 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/26 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/27 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/32 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/13 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
5.6%
1/18 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/17 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/28 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/30 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/4 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
|
Gastrointestinal disorders
Toothache
|
7.1%
1/14 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/26 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
3.7%
1/27 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/32 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/13 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
6.7%
1/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
6.7%
1/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/18 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
5.9%
1/17 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
5.3%
1/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/28 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/30 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/4 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
|
Gastrointestinal disorders
Vomiting
|
7.1%
1/14 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
7.7%
2/26 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
3.7%
1/27 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
6.2%
2/32 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
7.7%
1/13 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
6.7%
1/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
6.7%
1/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
11.1%
2/18 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
5.9%
1/17 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
15.8%
3/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
3.6%
1/28 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/30 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/4 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
|
General disorders
Asthenia
|
0.00%
0/14 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/26 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/27 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/32 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/13 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/18 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
11.8%
2/17 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/28 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/30 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/4 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
|
General disorders
Catheter site erythema
|
0.00%
0/14 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/26 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/27 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/32 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/13 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
6.7%
1/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/18 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/17 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/28 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/30 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/4 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
|
General disorders
Catheter site pain
|
0.00%
0/14 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/26 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/27 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/32 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/13 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
6.7%
1/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/18 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/17 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/28 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/30 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/4 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
|
General disorders
Chills
|
0.00%
0/14 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/26 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/27 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/32 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/13 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
5.6%
1/18 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/17 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/28 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/30 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/4 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
|
General disorders
Fatigue
|
21.4%
3/14 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
23.1%
6/26 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
18.5%
5/27 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
12.5%
4/32 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
15.4%
2/13 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
33.3%
5/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
13.3%
2/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
13.3%
2/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
16.7%
3/18 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
17.6%
3/17 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
10.5%
2/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
25.0%
7/28 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
10.0%
3/30 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
25.0%
1/4 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
|
General disorders
Feeling cold
|
0.00%
0/14 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/26 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/27 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/32 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/13 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
6.7%
1/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/18 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/17 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/28 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/30 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/4 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
|
General disorders
Generalised oedema
|
0.00%
0/14 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/26 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/27 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/32 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
7.7%
1/13 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/18 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/17 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/28 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/30 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/4 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
|
General disorders
Impaired healing
|
0.00%
0/14 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/26 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/27 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/32 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/13 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
6.7%
1/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/18 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/17 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/28 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/30 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/4 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
|
General disorders
Malaise
|
0.00%
0/14 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/26 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/27 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
3.1%
1/32 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/13 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
6.7%
1/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/18 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/17 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
3.6%
1/28 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
6.7%
2/30 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/4 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
|
General disorders
Peripheral swelling
|
0.00%
0/14 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/26 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/27 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
6.2%
2/32 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/13 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/18 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/17 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/28 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/30 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/4 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
|
General disorders
Pyrexia
|
0.00%
0/14 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/26 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/27 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/32 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
7.7%
1/13 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/18 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/17 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/28 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/30 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/4 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
|
General disorders
Thirst
|
0.00%
0/14 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/26 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/27 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/32 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/13 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/18 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/17 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
5.3%
1/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/28 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/30 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/4 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
|
Infections and infestations
Bronchitis
|
0.00%
0/14 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/26 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/27 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
3.1%
1/32 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
7.7%
1/13 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
6.7%
1/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/18 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/17 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
5.3%
1/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/28 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/30 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/4 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
|
Infections and infestations
Cellulitis
|
0.00%
0/14 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/26 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/27 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
3.1%
1/32 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/13 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/18 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
5.9%
1/17 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/28 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/30 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/4 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
|
Infections and infestations
Folliculitis
|
0.00%
0/14 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/26 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/27 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/32 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
7.7%
1/13 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/18 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/17 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/28 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/30 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/4 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
|
Infections and infestations
Gastroenteritis
|
14.3%
2/14 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
7.7%
2/26 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
7.4%
2/27 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/32 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/13 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
6.7%
1/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
6.7%
1/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
5.6%
1/18 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/17 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/28 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/30 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/4 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
|
Infections and infestations
Gingivitis
|
0.00%
0/14 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/26 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/27 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/32 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/13 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
6.7%
1/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/18 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/17 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/28 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/30 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/4 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
|
Infections and infestations
Hordeolum
|
0.00%
0/14 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
3.8%
1/26 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/27 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/32 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/13 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
6.7%
1/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/18 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/17 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/28 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/30 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/4 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
|
Infections and infestations
Lower respiratory tract infection viral
|
0.00%
0/14 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/26 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/27 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/32 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
7.7%
1/13 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/18 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/17 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/28 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/30 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/4 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/14 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/26 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/27 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/32 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/13 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
5.6%
1/18 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/17 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/28 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/30 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/4 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/14 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/26 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/27 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/32 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/13 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/18 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/17 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
5.3%
1/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/28 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/30 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/4 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
|
Infections and infestations
Oral herpes
|
0.00%
0/14 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
3.8%
1/26 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/27 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/32 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/13 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
6.7%
1/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/18 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/17 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/28 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/30 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/4 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
|
Infections and infestations
Otitis media
|
0.00%
0/14 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/26 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/27 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/32 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/13 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/18 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
5.9%
1/17 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/28 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
3.3%
1/30 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/4 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
|
Infections and infestations
Paronychia
|
0.00%
0/14 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/26 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/27 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/32 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
7.7%
1/13 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/18 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/17 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/28 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/30 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/4 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/14 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/26 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/27 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/32 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/13 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/18 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
5.9%
1/17 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/28 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/30 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/4 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
|
Infections and infestations
Skin infection
|
0.00%
0/14 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/26 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/27 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/32 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/13 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
5.6%
1/18 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/17 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/28 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/30 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/4 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
|
Infections and infestations
Upper respiratory tract infection
|
28.6%
4/14 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
15.4%
4/26 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/27 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
21.9%
7/32 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
7.7%
1/13 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
13.3%
2/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
22.2%
4/18 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/17 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
5.3%
1/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
14.3%
4/28 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
3.3%
1/30 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
25.0%
1/4 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/14 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/26 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
3.7%
1/27 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
3.1%
1/32 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/13 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
6.7%
1/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
5.6%
1/18 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/17 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
7.1%
2/28 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/30 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/4 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
|
Infections and infestations
Viral infection
|
7.1%
1/14 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/26 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/27 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/32 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/13 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
6.7%
1/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
6.7%
1/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/18 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/17 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
3.6%
1/28 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
10.0%
3/30 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/4 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/14 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/26 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/27 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
3.1%
1/32 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/13 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
5.6%
1/18 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
11.8%
2/17 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
10.5%
2/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
7.1%
2/28 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/30 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/4 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
|
Infections and infestations
Wound infection
|
0.00%
0/14 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/26 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/27 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
3.1%
1/32 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/13 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/18 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
5.9%
1/17 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/28 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/30 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/4 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.00%
0/14 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/26 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/27 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/32 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
7.7%
1/13 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/18 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/17 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/28 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/30 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/4 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.00%
0/14 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/26 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/27 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/32 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/13 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/18 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/17 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
5.3%
1/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/28 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/30 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/4 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
|
Injury, poisoning and procedural complications
Chemical burn of skin
|
0.00%
0/14 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/26 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/27 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/32 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/13 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
5.6%
1/18 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/17 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/28 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/30 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/4 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/14 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/26 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/27 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
3.1%
1/32 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/13 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/18 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
11.8%
2/17 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
5.3%
1/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
3.6%
1/28 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/30 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/4 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
|
Injury, poisoning and procedural complications
Foreign body in eye
|
0.00%
0/14 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/26 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/27 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/32 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/13 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/18 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/17 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
5.3%
1/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/28 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/30 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/4 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/14 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
3.8%
1/26 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/27 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/32 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/13 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
6.7%
1/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
11.1%
2/18 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
5.9%
1/17 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/28 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/30 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/4 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/14 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/26 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/27 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
3.1%
1/32 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/13 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/18 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
5.9%
1/17 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
5.3%
1/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
3.6%
1/28 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/30 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/4 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
|
Injury, poisoning and procedural complications
Muscle strain
|
7.1%
1/14 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
3.8%
1/26 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/27 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
3.1%
1/32 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/13 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
6.7%
1/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/18 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
5.9%
1/17 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
5.3%
1/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
3.6%
1/28 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/30 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/4 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
|
Injury, poisoning and procedural complications
Neck injury
|
0.00%
0/14 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/26 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/27 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/32 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/13 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
5.6%
1/18 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/17 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/28 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/30 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/4 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
|
Injury, poisoning and procedural complications
Skeletal injury
|
0.00%
0/14 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/26 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/27 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/32 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/13 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/18 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/17 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
5.3%
1/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/28 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/30 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/4 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/14 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/26 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/27 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
3.1%
1/32 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/13 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/18 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
5.9%
1/17 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
3.6%
1/28 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/30 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/4 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/14 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/26 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/27 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/32 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/13 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
6.7%
1/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
5.6%
1/18 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/17 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
3.6%
1/28 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/30 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/4 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
|
Investigations
Weight decreased
|
0.00%
0/14 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/26 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/27 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/32 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/13 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
6.7%
1/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/18 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/17 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/28 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
6.7%
2/30 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/4 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/14 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/26 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/27 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/32 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/13 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
6.7%
1/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
5.6%
1/18 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/17 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/28 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
3.3%
1/30 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/4 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/14 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/26 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/27 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/32 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
7.7%
1/13 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/18 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/17 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/28 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/30 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/4 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.00%
0/14 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/26 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/27 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/32 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
7.7%
1/13 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/18 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/17 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/28 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/30 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/4 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
7.1%
1/14 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/26 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/27 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
3.1%
1/32 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/13 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/18 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/17 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/28 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/30 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/4 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
|
Metabolism and nutrition disorders
Increased appetite
|
0.00%
0/14 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/26 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/27 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/32 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/13 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
6.7%
1/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/18 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/17 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/28 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/30 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/4 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.1%
1/14 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
3.8%
1/26 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/27 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
3.1%
1/32 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/13 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
6.7%
1/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/18 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/17 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
10.5%
2/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/28 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/30 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/4 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.1%
1/14 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
3.8%
1/26 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
7.4%
2/27 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/32 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/13 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/18 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/17 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
3.6%
1/28 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
3.3%
1/30 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/4 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
7.1%
1/14 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
3.8%
1/26 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/27 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/32 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/13 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/18 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/17 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/28 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/30 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/4 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
7.1%
1/14 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/26 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/27 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
3.1%
1/32 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
7.7%
1/13 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/18 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/17 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
3.6%
1/28 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/30 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/4 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/14 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/26 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
3.7%
1/27 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/32 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/13 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
13.3%
2/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/18 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/17 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
3.6%
1/28 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/30 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/4 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
14.3%
2/14 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/26 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/27 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/32 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/13 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
5.6%
1/18 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
11.8%
2/17 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
10.7%
3/28 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
3.3%
1/30 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/4 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/14 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/26 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/27 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/32 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
7.7%
1/13 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/18 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/17 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
5.3%
1/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
3.6%
1/28 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/30 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/4 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
7.1%
1/14 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/26 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/27 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/32 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/13 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/18 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/17 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/28 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/30 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/4 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/14 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
3.8%
1/26 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/27 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/32 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/13 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/18 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
5.9%
1/17 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/28 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/30 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/4 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.00%
0/14 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/26 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/27 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/32 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/13 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
5.6%
1/18 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/17 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/28 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/30 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/4 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Trigger finger
|
7.1%
1/14 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
3.8%
1/26 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/27 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/32 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/13 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/18 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/17 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/28 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/30 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/4 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/14 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/26 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/27 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/32 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/13 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
5.6%
1/18 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/17 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/28 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/30 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/4 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/14 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/26 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/27 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/32 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/13 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/18 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/17 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
5.3%
1/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/28 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/30 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/4 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
|
Nervous system disorders
Dizziness
|
0.00%
0/14 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/26 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/27 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/32 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
7.7%
1/13 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
6.7%
1/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/18 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/17 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
5.3%
1/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
7.1%
2/28 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
6.7%
2/30 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/4 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/14 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/26 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/27 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/32 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/13 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
6.7%
1/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/18 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
5.9%
1/17 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/28 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/30 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/4 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/14 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/26 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/27 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/32 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/13 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
5.6%
1/18 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/17 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/28 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/30 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/4 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
|
Nervous system disorders
Head discomfort
|
0.00%
0/14 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/26 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/27 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/32 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/13 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/18 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
5.9%
1/17 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/28 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/30 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/4 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
|
Nervous system disorders
Headache
|
42.9%
6/14 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
23.1%
6/26 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
25.9%
7/27 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
18.8%
6/32 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
7.7%
1/13 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
40.0%
6/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
13.3%
2/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
26.7%
4/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
33.3%
6/18 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
17.6%
3/17 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
21.1%
4/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
17.9%
5/28 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
20.0%
6/30 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
25.0%
1/4 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
|
Nervous system disorders
Lethargy
|
7.1%
1/14 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/26 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
3.7%
1/27 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
3.1%
1/32 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/13 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/18 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/17 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/28 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
6.7%
2/30 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/4 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/14 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/26 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/27 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/32 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/13 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
5.6%
1/18 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/17 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/28 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/30 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/4 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
|
Nervous system disorders
Migraine without aura
|
0.00%
0/14 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/26 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/27 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/32 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/13 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
5.6%
1/18 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/17 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/28 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/30 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/4 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/14 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/26 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/27 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/32 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/13 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
6.7%
1/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/18 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/17 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/28 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/30 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/4 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
|
Nervous system disorders
Presyncope
|
0.00%
0/14 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/26 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/27 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/32 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/13 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
6.7%
1/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/18 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/17 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/28 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/30 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/4 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
|
Nervous system disorders
Syncope
|
0.00%
0/14 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/26 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/27 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
3.1%
1/32 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/13 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
6.7%
1/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/18 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/17 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/28 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/30 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/4 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
|
Psychiatric disorders
Affect lability
|
7.1%
1/14 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/26 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/27 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/32 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/13 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/18 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/17 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/28 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/30 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/4 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
|
Psychiatric disorders
Depression
|
0.00%
0/14 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/26 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/27 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/32 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
7.7%
1/13 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/18 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/17 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/28 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/30 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/4 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
|
Psychiatric disorders
Insomnia
|
14.3%
2/14 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
3.8%
1/26 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
3.7%
1/27 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/32 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/13 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
6.7%
1/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/18 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/17 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
3.6%
1/28 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/30 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
25.0%
1/4 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
|
Psychiatric disorders
Irritability
|
14.3%
2/14 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
3.8%
1/26 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/27 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/32 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/13 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
5.6%
1/18 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
5.9%
1/17 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/28 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/30 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/4 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
|
Psychiatric disorders
Nightmare
|
0.00%
0/14 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/26 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/27 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/32 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/13 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
5.6%
1/18 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/17 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/28 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/30 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/4 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
|
Renal and urinary disorders
Dysuria
|
7.1%
1/14 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/26 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/27 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
3.1%
1/32 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/13 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/18 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/17 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/28 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/30 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/4 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
|
Renal and urinary disorders
Pollakiuria
|
7.1%
1/14 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/26 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
3.7%
1/27 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
3.1%
1/32 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/13 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/18 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/17 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/28 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/30 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/4 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/14 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/26 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/27 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/32 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/13 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
6.7%
1/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/18 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/17 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/28 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/30 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/4 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/14 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/26 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/27 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/32 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/13 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
6.7%
1/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/18 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/17 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/28 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/30 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/4 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/14 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/26 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
3.7%
1/27 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
6.2%
2/32 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/13 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/18 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/17 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/28 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/30 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/4 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/14 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/26 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/27 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
3.1%
1/32 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
7.7%
1/13 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/18 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/17 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
5.3%
1/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/28 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
3.3%
1/30 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/4 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/14 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/26 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/27 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
3.1%
1/32 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/13 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
6.7%
1/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/18 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/17 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
3.6%
1/28 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/30 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/4 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/14 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/26 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/27 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/32 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
7.7%
1/13 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/18 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/17 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/28 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/30 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/4 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
7.1%
1/14 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/26 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
3.7%
1/27 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
6.2%
2/32 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/13 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
6.7%
1/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/18 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/17 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
7.1%
2/28 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/30 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/4 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/14 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/26 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/27 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/32 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/13 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/18 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
5.9%
1/17 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/28 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/30 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/4 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/14 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
7.7%
2/26 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/27 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/32 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/13 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/18 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/17 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
3.6%
1/28 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/30 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/4 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/14 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/26 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/27 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/32 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/13 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
5.6%
1/18 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/17 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/28 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/30 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/4 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
14.3%
2/14 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/26 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/27 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/32 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/13 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
6.7%
1/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
5.6%
1/18 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
5.9%
1/17 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/28 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
3.3%
1/30 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/4 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
|
Skin and subcutaneous tissue disorders
Rash
|
21.4%
3/14 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
11.5%
3/26 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
7.4%
2/27 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/32 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
15.4%
2/13 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
5.6%
1/18 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/17 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/28 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
3.3%
1/30 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/4 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
7.1%
1/14 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/26 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/27 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/32 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
7.7%
1/13 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/18 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/17 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/28 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/30 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/4 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
14.3%
2/14 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/26 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/27 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/32 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
7.7%
1/13 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
5.6%
1/18 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/17 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/28 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/30 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/4 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.00%
0/14 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/26 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/27 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/32 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/13 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
5.6%
1/18 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/17 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/28 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/30 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/4 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/14 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/26 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/27 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/32 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/13 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
6.7%
1/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/18 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/17 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/28 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/30 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/4 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
|
Vascular disorders
Haematoma
|
0.00%
0/14 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/26 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/27 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/32 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/13 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
5.6%
1/18 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
5.9%
1/17 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/28 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/30 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/4 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
|
Vascular disorders
Hypertension
|
0.00%
0/14 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/26 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/27 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/32 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/13 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
6.7%
1/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/15 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/18 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/17 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/28 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/30 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
0.00%
0/4 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met: * The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or * The study has been completed at all study sites for at least 2 years
- Publication restrictions are in place
Restriction type: OTHER