Trial Outcomes & Findings for Open-Labeled Study of PSI-7977 and RBV With and Without PEG-IFN in Treatment-Naïve Patients With HCV GT2 or GT3 (NCT NCT01260350)
NCT ID: NCT01260350
Last Updated: 2014-11-17
Results Overview
Adverse events (AEs) occurring from baseline (Day 1 for all groups) to 30 days following the last dose of study drug were summarized across the participant population. A participant was counted once if they had a qualifying event.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
292 participants
Primary outcome timeframe
Up to 12 weeks plus 30 days
Results posted on
2014-11-17
Participant Flow
Participants were enrolled in a total of 2 study sites in New Zealand. The first participant was screened on 18 November 2010. The last participant observation was on 23 December 2013.
Participant milestones
| Measure |
Group 1: SOF+RBV 12 wk: GT 2 or 3, TN
Sofosbuvir (SOF) 400 mg once daily plus weight-based ribavirin (RBV) (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive (TN) participants with genotype (GT) 2 or 3 HCV infection
|
Group 2: SOF+RBV 12 wk +PEG 4 wk: GT 2 or 3, TN
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 4 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
|
Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
|
Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
|
Group 5: SOF 12 wk: GT 2 or 3, TN
SOF 400 mg once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
|
Group 6: SOF+RBV+PEG 8 wk: GT 2 or 3, TN
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
|
Group 7: SOF+RBV 12 wk: GT 1, TE
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection who did not respond to prior treatment
|
Group 8: SOF+RBV 12 wk: GT 1, TN
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 1 HCV infection
|
Group 9: SOF+RBV 12 wk: GT 2 or 3, TE
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 2 or 3 HCV infection
|
Group 10: SOF+RBV 8 wk: GT 2 or 3, TN
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
|
Group 11: SOF+RBV 12 wk: GT 2 or 3, TN
SOF 400 mg once daily plus split-dose RBV (800 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
|
Group 12: SOF+RBV+LDV 12 wk: GT 1, TE
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus ledipasvir (LDV) 90 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
|
Group 13: SOF+RBV+LDV 12 wk: GT 1, TN
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
|
Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
|
Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
|
Group 16: LDV/SOF FDC 12 wk: GT 1, Fibrosis
LDV 90 mg/SOF 400 mg fixed-dose combination (FDC) once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
|
Group 17: LDV/SOF FDC+RBV 12 wk: GT 1, Fibrosis
LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
|
Group 18: LDV/SOF FDC 12 wk: GT 2 or 3, TN
LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
|
Group 19: LDV/SOF FDC 12 wk: GT 2 or 3, TE
LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-experienced participants with genotype 2 or 3 HCV infection
|
Group 20: LDV/SOF FDC+RBV 12 wk: GT 1, Hemophiliac
LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in hemophiliac participants with genotype 1 HCV infection
|
Group 21: LDV/SOF FDC+RBV 6 wk: GT 1, TN
LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 6 weeks in treatment-naive participants with genotype 1 HCV infection
|
Group 22: LDV/SOF FDC 6 wk: GT 1, TN
Treatment-naive participants with genotype 1 HCV infection were randomized to receive LDV 90 mg/SOF 400 mg FDC once daily for 6 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
10
|
9
|
10
|
11
|
10
|
10
|
10
|
25
|
25
|
25
|
10
|
9
|
25
|
10
|
25
|
10
|
9
|
10
|
0
|
14
|
25
|
0
|
|
Overall Study
COMPLETED
|
10
|
9
|
10
|
11
|
10
|
10
|
10
|
25
|
24
|
25
|
10
|
9
|
25
|
10
|
25
|
10
|
9
|
9
|
0
|
14
|
22
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
3
|
0
|
Reasons for withdrawal
| Measure |
Group 1: SOF+RBV 12 wk: GT 2 or 3, TN
Sofosbuvir (SOF) 400 mg once daily plus weight-based ribavirin (RBV) (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive (TN) participants with genotype (GT) 2 or 3 HCV infection
|
Group 2: SOF+RBV 12 wk +PEG 4 wk: GT 2 or 3, TN
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 4 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
|
Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
|
Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
|
Group 5: SOF 12 wk: GT 2 or 3, TN
SOF 400 mg once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
|
Group 6: SOF+RBV+PEG 8 wk: GT 2 or 3, TN
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
|
Group 7: SOF+RBV 12 wk: GT 1, TE
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection who did not respond to prior treatment
|
Group 8: SOF+RBV 12 wk: GT 1, TN
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 1 HCV infection
|
Group 9: SOF+RBV 12 wk: GT 2 or 3, TE
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 2 or 3 HCV infection
|
Group 10: SOF+RBV 8 wk: GT 2 or 3, TN
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
|
Group 11: SOF+RBV 12 wk: GT 2 or 3, TN
SOF 400 mg once daily plus split-dose RBV (800 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
|
Group 12: SOF+RBV+LDV 12 wk: GT 1, TE
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus ledipasvir (LDV) 90 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
|
Group 13: SOF+RBV+LDV 12 wk: GT 1, TN
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
|
Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
|
Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
|
Group 16: LDV/SOF FDC 12 wk: GT 1, Fibrosis
LDV 90 mg/SOF 400 mg fixed-dose combination (FDC) once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
|
Group 17: LDV/SOF FDC+RBV 12 wk: GT 1, Fibrosis
LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
|
Group 18: LDV/SOF FDC 12 wk: GT 2 or 3, TN
LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
|
Group 19: LDV/SOF FDC 12 wk: GT 2 or 3, TE
LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-experienced participants with genotype 2 or 3 HCV infection
|
Group 20: LDV/SOF FDC+RBV 12 wk: GT 1, Hemophiliac
LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in hemophiliac participants with genotype 1 HCV infection
|
Group 21: LDV/SOF FDC+RBV 6 wk: GT 1, TN
LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 6 weeks in treatment-naive participants with genotype 1 HCV infection
|
Group 22: LDV/SOF FDC 6 wk: GT 1, TN
Treatment-naive participants with genotype 1 HCV infection were randomized to receive LDV 90 mg/SOF 400 mg FDC once daily for 6 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Lack of Efficacy
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
3
|
0
|
|
Overall Study
Did Not Complete Follow-up 12 Visit
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Open-Labeled Study of PSI-7977 and RBV With and Without PEG-IFN in Treatment-Naïve Patients With HCV GT2 or GT3
Baseline characteristics by cohort
| Measure |
Group 1: SOF+RBV 12 wk: GT 2 or 3, TN
n=10 Participants
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive (TN) participants with genotype (GT) 2 or 3 HCV infection
|
Group 2: SOF+RBV 12 wk +PEG 4 wk: GT 2 or 3, TN
n=9 Participants
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 4 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
|
Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN
n=10 Participants
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
|
Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN
n=11 Participants
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
|
Group 5: SOF 12 wk: GT 2 or 3, TN
n=10 Participants
SOF 400 mg once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
|
Group 6: SOF+RBV+PEG 8 wk: GT 2 or 3, TN
n=10 Participants
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
|
Group 7: SOF+RBV 12 wk: GT 1, TE
n=10 Participants
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection who did not respond to prior treatment
|
Group 8: SOF+RBV 12 wk: GT 1, TN
n=25 Participants
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 1 HCV infection
|
Group 9: SOF+RBV 12 wk: GT 2 or 3, TE
n=25 Participants
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 2 or 3 HCV infection
|
Group 10: SOF+RBV 8 wk: GT 2 or 3, TN
n=25 Participants
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
|
Group 11: SOF+RBV 12 wk: GT 2 or 3, TN
n=10 Participants
SOF 400 mg once daily plus split-dose RBV (800 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
|
Group 12: SOF+RBV+LDV 12 wk: GT 1, TE
n=9 Participants
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
|
Group 13: SOF+RBV+LDV 12 wk: GT 1, TN
n=25 Participants
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
|
Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE
n=10 Participants
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
|
Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN
n=25 Participants
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
|
Group 16: LDV/SOF FDC 12 wk: GT 1, Fibrosis
n=10 Participants
LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
|
Group 17: LDV/SOF FDC+RBV 12 wk: GT 1, Fibrosis
n=9 Participants
LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
|
Group 18: LDV/SOF FDC 12 wk: GT 2 or 3, TN
n=10 Participants
LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
|
Group 20: LDV/SOF FDC+RBV 12 wk: GT 1, Hemophiliac
n=14 Participants
LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in hemophiliac participants with genotype 1 HCV infection
|
Group 21: LDV/SOF FDC+RBV 6 wk: GT 1, TN
n=25 Participants
LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 6 weeks in treatment-naive participants with genotype 1 HCV infection
|
Total
n=292 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
47 years
STANDARD_DEVIATION 6.0 • n=5 Participants
|
47 years
STANDARD_DEVIATION 10.2 • n=7 Participants
|
49 years
STANDARD_DEVIATION 9.9 • n=5 Participants
|
46 years
STANDARD_DEVIATION 6.3 • n=4 Participants
|
43 years
STANDARD_DEVIATION 13.5 • n=21 Participants
|
39 years
STANDARD_DEVIATION 12.2 • n=8 Participants
|
48 years
STANDARD_DEVIATION 10.4 • n=8 Participants
|
48 years
STANDARD_DEVIATION 11.4 • n=24 Participants
|
53 years
STANDARD_DEVIATION 7.9 • n=42 Participants
|
48 years
STANDARD_DEVIATION 9.4 • n=42 Participants
|
39 years
STANDARD_DEVIATION 8.9 • n=42 Participants
|
50 years
STANDARD_DEVIATION 13.0 • n=42 Participants
|
45 years
STANDARD_DEVIATION 9.2 • n=36 Participants
|
55 years
STANDARD_DEVIATION 6.0 • n=36 Participants
|
46 years
STANDARD_DEVIATION 9.3 • n=24 Participants
|
61 years
STANDARD_DEVIATION 4.9 • n=135 Participants
|
57 years
STANDARD_DEVIATION 5.2 • n=136 Participants
|
39 years
STANDARD_DEVIATION 10.8 • n=44 Participants
|
54 years
STANDARD_DEVIATION 13.0 • n=667 Participants
|
51 years
STANDARD_DEVIATION 9.0 • n=12 Participants
|
48 years
STANDARD_DEVIATION 10.6 • n=12 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
10 Participants
n=24 Participants
|
6 Participants
n=42 Participants
|
8 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
17 Participants
n=36 Participants
|
3 Participants
n=36 Participants
|
12 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
1 Participants
n=136 Participants
|
7 Participants
n=44 Participants
|
2 Participants
n=667 Participants
|
12 Participants
n=12 Participants
|
110 Participants
n=12 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
7 Participants
n=8 Participants
|
15 Participants
n=24 Participants
|
19 Participants
n=42 Participants
|
17 Participants
n=42 Participants
|
7 Participants
n=42 Participants
|
7 Participants
n=42 Participants
|
8 Participants
n=36 Participants
|
7 Participants
n=36 Participants
|
13 Participants
n=24 Participants
|
10 Participants
n=135 Participants
|
8 Participants
n=136 Participants
|
3 Participants
n=44 Participants
|
12 Participants
n=667 Participants
|
13 Participants
n=12 Participants
|
182 Participants
n=12 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
2 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
0 Participants
n=12 Participants
|
3 Participants
n=12 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
9 Participants
n=8 Participants
|
10 Participants
n=8 Participants
|
25 Participants
n=24 Participants
|
25 Participants
n=42 Participants
|
25 Participants
n=42 Participants
|
10 Participants
n=42 Participants
|
9 Participants
n=42 Participants
|
25 Participants
n=36 Participants
|
10 Participants
n=36 Participants
|
25 Participants
n=24 Participants
|
8 Participants
n=135 Participants
|
9 Participants
n=136 Participants
|
10 Participants
n=44 Participants
|
14 Participants
n=667 Participants
|
25 Participants
n=12 Participants
|
289 Participants
n=12 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
|
Race/Ethnicity, Customized
White
|
7 participants
n=5 Participants
|
4 participants
n=7 Participants
|
8 participants
n=5 Participants
|
9 participants
n=4 Participants
|
10 participants
n=21 Participants
|
7 participants
n=8 Participants
|
9 participants
n=8 Participants
|
20 participants
n=24 Participants
|
17 participants
n=42 Participants
|
20 participants
n=42 Participants
|
9 participants
n=42 Participants
|
9 participants
n=42 Participants
|
23 participants
n=36 Participants
|
9 participants
n=36 Participants
|
20 participants
n=24 Participants
|
8 participants
n=135 Participants
|
9 participants
n=136 Participants
|
7 participants
n=44 Participants
|
12 participants
n=667 Participants
|
22 participants
n=12 Participants
|
239 participants
n=12 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=8 Participants
|
0 participants
n=8 Participants
|
2 participants
n=24 Participants
|
0 participants
n=42 Participants
|
1 participants
n=42 Participants
|
1 participants
n=42 Participants
|
0 participants
n=42 Participants
|
0 participants
n=36 Participants
|
0 participants
n=36 Participants
|
1 participants
n=24 Participants
|
0 participants
n=135 Participants
|
0 participants
n=136 Participants
|
3 participants
n=44 Participants
|
1 participants
n=667 Participants
|
0 participants
n=12 Participants
|
11 participants
n=12 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian of Other Pacific Islander
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=8 Participants
|
0 participants
n=8 Participants
|
0 participants
n=24 Participants
|
2 participants
n=42 Participants
|
1 participants
n=42 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
1 participants
n=36 Participants
|
0 participants
n=36 Participants
|
0 participants
n=24 Participants
|
0 participants
n=135 Participants
|
0 participants
n=136 Participants
|
0 participants
n=44 Participants
|
0 participants
n=667 Participants
|
1 participants
n=12 Participants
|
5 participants
n=12 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=8 Participants
|
0 participants
n=8 Participants
|
0 participants
n=24 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
0 participants
n=36 Participants
|
0 participants
n=36 Participants
|
0 participants
n=24 Participants
|
0 participants
n=135 Participants
|
0 participants
n=136 Participants
|
0 participants
n=44 Participants
|
0 participants
n=667 Participants
|
0 participants
n=12 Participants
|
1 participants
n=12 Participants
|
|
Race/Ethnicity, Customized
Other
|
3 participants
n=5 Participants
|
4 participants
n=7 Participants
|
0 participants
n=5 Participants
|
2 participants
n=4 Participants
|
0 participants
n=21 Participants
|
3 participants
n=8 Participants
|
1 participants
n=8 Participants
|
3 participants
n=24 Participants
|
6 participants
n=42 Participants
|
3 participants
n=42 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
1 participants
n=36 Participants
|
1 participants
n=36 Participants
|
4 participants
n=24 Participants
|
2 participants
n=135 Participants
|
0 participants
n=136 Participants
|
0 participants
n=44 Participants
|
1 participants
n=667 Participants
|
2 participants
n=12 Participants
|
36 participants
n=12 Participants
|
|
Hepatitis C Virus (HCV) RNA
|
6.7 log10 IU/mL
STANDARD_DEVIATION 0.42 • n=5 Participants
|
6.6 log10 IU/mL
STANDARD_DEVIATION 0.52 • n=7 Participants
|
6.4 log10 IU/mL
STANDARD_DEVIATION 0.57 • n=5 Participants
|
6.3 log10 IU/mL
STANDARD_DEVIATION 0.76 • n=4 Participants
|
5.7 log10 IU/mL
STANDARD_DEVIATION 0.89 • n=21 Participants
|
6.1 log10 IU/mL
STANDARD_DEVIATION 0.88 • n=8 Participants
|
6.8 log10 IU/mL
STANDARD_DEVIATION 0.55 • n=8 Participants
|
6.1 log10 IU/mL
STANDARD_DEVIATION 0.75 • n=24 Participants
|
6.5 log10 IU/mL
STANDARD_DEVIATION 0.66 • n=42 Participants
|
6.1 log10 IU/mL
STANDARD_DEVIATION 0.80 • n=42 Participants
|
6.2 log10 IU/mL
STANDARD_DEVIATION 0.96 • n=42 Participants
|
6.9 log10 IU/mL
STANDARD_DEVIATION 0.20 • n=42 Participants
|
5.9 log10 IU/mL
STANDARD_DEVIATION 0.85 • n=36 Participants
|
7.0 log10 IU/mL
STANDARD_DEVIATION 0.38 • n=36 Participants
|
6.3 log10 IU/mL
STANDARD_DEVIATION 0.54 • n=24 Participants
|
6.5 log10 IU/mL
STANDARD_DEVIATION 0.57 • n=135 Participants
|
6.3 log10 IU/mL
STANDARD_DEVIATION 0.78 • n=136 Participants
|
6.1 log10 IU/mL
STANDARD_DEVIATION 0.94 • n=44 Participants
|
6.5 log10 IU/mL
STANDARD_DEVIATION 0.51 • n=667 Participants
|
6.5 log10 IU/mL
STANDARD_DEVIATION 0.56 • n=12 Participants
|
6.3 log10 IU/mL
STANDARD_DEVIATION 0.73 • n=12 Participants
|
|
HCV RNA Category
< 6 log10 IU/mL
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
3 participants
n=4 Participants
|
5 participants
n=21 Participants
|
5 participants
n=8 Participants
|
1 participants
n=8 Participants
|
10 participants
n=24 Participants
|
5 participants
n=42 Participants
|
12 participants
n=42 Participants
|
4 participants
n=42 Participants
|
0 participants
n=42 Participants
|
11 participants
n=36 Participants
|
0 participants
n=36 Participants
|
8 participants
n=24 Participants
|
2 participants
n=135 Participants
|
3 participants
n=136 Participants
|
5 participants
n=44 Participants
|
2 participants
n=667 Participants
|
6 participants
n=12 Participants
|
87 participants
n=12 Participants
|
|
HCV RNA Category
≥ 6 log10 IU/mL
|
9 participants
n=5 Participants
|
8 participants
n=7 Participants
|
7 participants
n=5 Participants
|
8 participants
n=4 Participants
|
5 participants
n=21 Participants
|
5 participants
n=8 Participants
|
9 participants
n=8 Participants
|
15 participants
n=24 Participants
|
20 participants
n=42 Participants
|
13 participants
n=42 Participants
|
6 participants
n=42 Participants
|
9 participants
n=42 Participants
|
14 participants
n=36 Participants
|
10 participants
n=36 Participants
|
17 participants
n=24 Participants
|
8 participants
n=135 Participants
|
6 participants
n=136 Participants
|
5 participants
n=44 Participants
|
12 participants
n=667 Participants
|
19 participants
n=12 Participants
|
205 participants
n=12 Participants
|
|
HCV Genotype
Genotype 1
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=8 Participants
|
10 participants
n=8 Participants
|
25 participants
n=24 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
9 participants
n=42 Participants
|
25 participants
n=36 Participants
|
10 participants
n=36 Participants
|
25 participants
n=24 Participants
|
10 participants
n=135 Participants
|
9 participants
n=136 Participants
|
0 participants
n=44 Participants
|
14 participants
n=667 Participants
|
25 participants
n=12 Participants
|
162 participants
n=12 Participants
|
|
HCV Genotype
Genotype 2
|
4 participants
n=5 Participants
|
3 participants
n=7 Participants
|
4 participants
n=5 Participants
|
4 participants
n=4 Participants
|
3 participants
n=21 Participants
|
0 participants
n=8 Participants
|
0 participants
n=8 Participants
|
0 participants
n=24 Participants
|
6 participants
n=42 Participants
|
5 participants
n=42 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
0 participants
n=36 Participants
|
0 participants
n=36 Participants
|
0 participants
n=24 Participants
|
0 participants
n=135 Participants
|
0 participants
n=136 Participants
|
2 participants
n=44 Participants
|
0 participants
n=667 Participants
|
0 participants
n=12 Participants
|
31 participants
n=12 Participants
|
|
HCV Genotype
Genotype 3
|
6 participants
n=5 Participants
|
6 participants
n=7 Participants
|
6 participants
n=5 Participants
|
7 participants
n=4 Participants
|
7 participants
n=21 Participants
|
10 participants
n=8 Participants
|
0 participants
n=8 Participants
|
0 participants
n=24 Participants
|
19 participants
n=42 Participants
|
20 participants
n=42 Participants
|
10 participants
n=42 Participants
|
0 participants
n=42 Participants
|
0 participants
n=36 Participants
|
0 participants
n=36 Participants
|
0 participants
n=24 Participants
|
0 participants
n=135 Participants
|
0 participants
n=136 Participants
|
8 participants
n=44 Participants
|
0 participants
n=667 Participants
|
0 participants
n=12 Participants
|
99 participants
n=12 Participants
|
|
IL28b Genotype
CC
|
5 participants
n=5 Participants
|
4 participants
n=7 Participants
|
4 participants
n=5 Participants
|
4 participants
n=4 Participants
|
2 participants
n=21 Participants
|
3 participants
n=8 Participants
|
10 participants
n=8 Participants
|
25 participants
n=24 Participants
|
0 participants
n=42 Participants
|
13 participants
n=42 Participants
|
4 participants
n=42 Participants
|
0 participants
n=42 Participants
|
9 participants
n=36 Participants
|
1 participants
n=36 Participants
|
7 participants
n=24 Participants
|
4 participants
n=135 Participants
|
2 participants
n=136 Participants
|
3 participants
n=44 Participants
|
4 participants
n=667 Participants
|
5 participants
n=12 Participants
|
109 participants
n=12 Participants
|
|
IL28b Genotype
CT
|
4 participants
n=5 Participants
|
4 participants
n=7 Participants
|
4 participants
n=5 Participants
|
5 participants
n=4 Participants
|
6 participants
n=21 Participants
|
6 participants
n=8 Participants
|
0 participants
n=8 Participants
|
0 participants
n=24 Participants
|
6 participants
n=42 Participants
|
12 participants
n=42 Participants
|
5 participants
n=42 Participants
|
7 participants
n=42 Participants
|
14 participants
n=36 Participants
|
8 participants
n=36 Participants
|
14 participants
n=24 Participants
|
4 participants
n=135 Participants
|
5 participants
n=136 Participants
|
6 participants
n=44 Participants
|
7 participants
n=667 Participants
|
15 participants
n=12 Participants
|
132 participants
n=12 Participants
|
|
IL28b Genotype
TT
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
2 participants
n=4 Participants
|
2 participants
n=21 Participants
|
1 participants
n=8 Participants
|
0 participants
n=8 Participants
|
0 participants
n=24 Participants
|
19 participants
n=42 Participants
|
0 participants
n=42 Participants
|
1 participants
n=42 Participants
|
2 participants
n=42 Participants
|
2 participants
n=36 Participants
|
1 participants
n=36 Participants
|
4 participants
n=24 Participants
|
2 participants
n=135 Participants
|
2 participants
n=136 Participants
|
1 participants
n=44 Participants
|
3 participants
n=667 Participants
|
5 participants
n=12 Participants
|
51 participants
n=12 Participants
|
|
Cirrhosis Status
Yes
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=8 Participants
|
0 participants
n=8 Participants
|
0 participants
n=24 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
0 participants
n=36 Participants
|
0 participants
n=36 Participants
|
0 participants
n=24 Participants
|
10 participants
n=135 Participants
|
9 participants
n=136 Participants
|
0 participants
n=44 Participants
|
1 participants
n=667 Participants
|
0 participants
n=12 Participants
|
20 participants
n=12 Participants
|
|
Cirrhosis Status
No
|
10 participants
n=5 Participants
|
9 participants
n=7 Participants
|
10 participants
n=5 Participants
|
11 participants
n=4 Participants
|
10 participants
n=21 Participants
|
10 participants
n=8 Participants
|
10 participants
n=8 Participants
|
25 participants
n=24 Participants
|
25 participants
n=42 Participants
|
25 participants
n=42 Participants
|
10 participants
n=42 Participants
|
9 participants
n=42 Participants
|
25 participants
n=36 Participants
|
10 participants
n=36 Participants
|
25 participants
n=24 Participants
|
0 participants
n=135 Participants
|
0 participants
n=136 Participants
|
10 participants
n=44 Participants
|
13 participants
n=667 Participants
|
25 participants
n=12 Participants
|
272 participants
n=12 Participants
|
PRIMARY outcome
Timeframe: Up to 12 weeks plus 30 daysPopulation: Safety Analysis Set: participants were randomized and received at least one dose of study medication.
Adverse events (AEs) occurring from baseline (Day 1 for all groups) to 30 days following the last dose of study drug were summarized across the participant population. A participant was counted once if they had a qualifying event.
Outcome measures
| Measure |
Group 5: SOF 12 wk: GT 2 or 3, TN
n=10 Participants
SOF 400 mg once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
|
Group 6: SOF+RBV+PEG 8 wk: GT 2 or 3, TN
n=10 Participants
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
|
Group 7: SOF+RBV 12 wk: GT 1, TE
n=10 Participants
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection who did not respond to prior treatment
|
Group 1: SOF+RBV 12 wk: GT 2 or 3, TN
n=10 Participants
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive (TN) participants with genotype (GT) 2 or 3 HCV infection
|
Group 2: SOF+RBV 12 wk +PEG 4 wk: GT 2 or 3, TN
n=9 Participants
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 4 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
|
Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN
n=10 Participants
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
|
Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN
n=11 Participants
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
|
Group 8: SOF+RBV 12 wk: GT 1, TN
n=25 Participants
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 1 HCV infection
|
Group 9: SOF+RBV 12 wk: GT 2 or 3, TE
n=25 Participants
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 2 or 3 HCV infection
|
Group 10: SOF+RBV 8 wk: GT 2 or 3, TN
n=25 Participants
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
|
Group 11: SOF+RBV 12 wk: GT 2 or 3, TN
n=10 Participants
SOF 400 mg once daily plus split-dose RBV (800 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
|
Group 12: SOF+RBV+LDV 12 wk: GT 1, TE
n=9 Participants
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
|
Group 13: SOF+RBV+LDV 12 wk: GT 1, TN
n=25 Participants
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
|
Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE
n=10 Participants
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
|
Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN
n=25 Participants
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
|
Group 16: LDV/SOF FDC 12 wk: GT 1, Fibrosis
n=10 Participants
LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
|
Group 17: LDV/SOF FDC+RBV 12 wk: GT 1, Fibrosis
n=9 Participants
LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
|
Group 18: LDV/SOF FDC 12 wk: GT 2 or 3, TN
n=10 Participants
LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
|
Group 20: LDV/SOF FDC+RBV 12 wk: GT 1, Hemophiliac
n=14 Participants
LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in hemophiliac participants with genotype 1 HCV infection
|
Group 21: LDV/SOF FDC+RBV 6 wk: GT 1, TN
n=25 Participants
LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 6 weeks in treatment-naive participants with genotype 1 HCV infection
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Who Experienced Adverse Events
AE leading to drug discontinuation
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
1 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
1 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
3 Percentage of participants
|
2 Percentage of participants
|
|
Percentage of Participants Who Experienced Adverse Events
Serious AE
|
0 Percentage of participants
|
1 Percentage of participants
|
0 Percentage of participants
|
1 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
1 Percentage of participants
|
0 Percentage of participants
|
2 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
2 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
2 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Who Experienced Adverse Events
Any AE
|
10 Percentage of participants
|
10 Percentage of participants
|
10 Percentage of participants
|
10 Percentage of participants
|
9 Percentage of participants
|
10 Percentage of participants
|
11 Percentage of participants
|
25 Percentage of participants
|
24 Percentage of participants
|
25 Percentage of participants
|
10 Percentage of participants
|
9 Percentage of participants
|
24 Percentage of participants
|
10 Percentage of participants
|
25 Percentage of participants
|
7 Percentage of participants
|
8 Percentage of participants
|
7 Percentage of participants
|
13 Percentage of participants
|
22 Percentage of participants
|
|
Percentage of Participants Who Experienced Adverse Events
Drug-related AE
|
7 Percentage of participants
|
10 Percentage of participants
|
10 Percentage of participants
|
8 Percentage of participants
|
9 Percentage of participants
|
10 Percentage of participants
|
11 Percentage of participants
|
25 Percentage of participants
|
20 Percentage of participants
|
21 Percentage of participants
|
7 Percentage of participants
|
9 Percentage of participants
|
24 Percentage of participants
|
10 Percentage of participants
|
21 Percentage of participants
|
5 Percentage of participants
|
8 Percentage of participants
|
6 Percentage of participants
|
12 Percentage of participants
|
19 Percentage of participants
|
|
Percentage of Participants Who Experienced Adverse Events
Grade 3 or higher AE
|
0 Percentage of participants
|
3 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
2 Percentage of participants
|
0 Percentage of participants
|
1 Percentage of participants
|
1 Percentage of participants
|
0 Percentage of participants
|
1 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
3 Percentage of participants
|
0 Percentage of participants
|
2 Percentage of participants
|
0 Percentage of participants
|
1 Percentage of participants
|
0 Percentage of participants
|
1 Percentage of participants
|
0 Percentage of participants
|
SECONDARY outcome
Timeframe: Posttreatment Week 12Population: Safety Analysis Set
SVR12 was defined as HCV RNA \< the limit of detection (LOD; \< 15 IU/mL) 12 weeks after the last dose of study drug.
Outcome measures
| Measure |
Group 5: SOF 12 wk: GT 2 or 3, TN
n=10 Participants
SOF 400 mg once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
|
Group 6: SOF+RBV+PEG 8 wk: GT 2 or 3, TN
n=10 Participants
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
|
Group 7: SOF+RBV 12 wk: GT 1, TE
n=10 Participants
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection who did not respond to prior treatment
|
Group 1: SOF+RBV 12 wk: GT 2 or 3, TN
n=10 Participants
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive (TN) participants with genotype (GT) 2 or 3 HCV infection
|
Group 2: SOF+RBV 12 wk +PEG 4 wk: GT 2 or 3, TN
n=9 Participants
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 4 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
|
Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN
n=10 Participants
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
|
Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN
n=11 Participants
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
|
Group 8: SOF+RBV 12 wk: GT 1, TN
n=25 Participants
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 1 HCV infection
|
Group 9: SOF+RBV 12 wk: GT 2 or 3, TE
n=25 Participants
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 2 or 3 HCV infection
|
Group 10: SOF+RBV 8 wk: GT 2 or 3, TN
n=25 Participants
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
|
Group 11: SOF+RBV 12 wk: GT 2 or 3, TN
n=10 Participants
SOF 400 mg once daily plus split-dose RBV (800 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
|
Group 12: SOF+RBV+LDV 12 wk: GT 1, TE
n=9 Participants
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
|
Group 13: SOF+RBV+LDV 12 wk: GT 1, TN
n=25 Participants
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
|
Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE
n=10 Participants
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
|
Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN
n=25 Participants
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
|
Group 16: LDV/SOF FDC 12 wk: GT 1, Fibrosis
n=10 Participants
LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
|
Group 17: LDV/SOF FDC+RBV 12 wk: GT 1, Fibrosis
n=9 Participants
LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
|
Group 18: LDV/SOF FDC 12 wk: GT 2 or 3, TN
n=10 Participants
LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
|
Group 20: LDV/SOF FDC+RBV 12 wk: GT 1, Hemophiliac
n=14 Participants
LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in hemophiliac participants with genotype 1 HCV infection
|
Group 21: LDV/SOF FDC+RBV 6 wk: GT 1, TN
n=25 Participants
LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 6 weeks in treatment-naive participants with genotype 1 HCV infection
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Sustained Virologic Response 12 Weeks Following Completion of Treatment (SVR12)
|
60.0 percentage of participants
Interval 26.2 to 87.8
|
100.0 percentage of participants
Interval 69.2 to 100.0
|
10.0 percentage of participants
Interval 0.3 to 44.5
|
100.0 percentage of participants
Interval 69.2 to 100.0
|
100.0 percentage of participants
Interval 66.4 to 100.0
|
100.0 percentage of participants
Interval 69.2 to 100.0
|
100.0 percentage of participants
Interval 71.5 to 100.0
|
84.0 percentage of participants
Interval 63.9 to 9.0
|
68.0 percentage of participants
|
64.0 percentage of participants
Interval 42.5 to 82.0
|
60.0 percentage of participants
Interval 26.2 to 87.8
|
100.0 percentage of participants
Interval 66.4 to 100.0
|
100.0 percentage of participants
Interval 86.3 to 100.0
|
100.0 percentage of participants
Interval 69.2 to 100.0
|
92.0 percentage of participants
Interval 74.0 to 99.0
|
70.0 percentage of participants
|
100.0 percentage of participants
|
80.0 percentage of participants
|
100.0 percentage of participants
|
68.0 percentage of participants
|
SECONDARY outcome
Timeframe: Week 6Population: Safety Analysis Set
Outcome measures
| Measure |
Group 5: SOF 12 wk: GT 2 or 3, TN
n=10 Participants
SOF 400 mg once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
|
Group 6: SOF+RBV+PEG 8 wk: GT 2 or 3, TN
n=10 Participants
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
|
Group 7: SOF+RBV 12 wk: GT 1, TE
n=10 Participants
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection who did not respond to prior treatment
|
Group 1: SOF+RBV 12 wk: GT 2 or 3, TN
n=10 Participants
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive (TN) participants with genotype (GT) 2 or 3 HCV infection
|
Group 2: SOF+RBV 12 wk +PEG 4 wk: GT 2 or 3, TN
n=9 Participants
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 4 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
|
Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN
n=10 Participants
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
|
Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN
n=11 Participants
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
|
Group 8: SOF+RBV 12 wk: GT 1, TN
n=25 Participants
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 1 HCV infection
|
Group 9: SOF+RBV 12 wk: GT 2 or 3, TE
n=25 Participants
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 2 or 3 HCV infection
|
Group 10: SOF+RBV 8 wk: GT 2 or 3, TN
n=25 Participants
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
|
Group 11: SOF+RBV 12 wk: GT 2 or 3, TN
n=10 Participants
SOF 400 mg once daily plus split-dose RBV (800 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
|
Group 12: SOF+RBV+LDV 12 wk: GT 1, TE
n=9 Participants
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
|
Group 13: SOF+RBV+LDV 12 wk: GT 1, TN
n=25 Participants
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
|
Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE
n=10 Participants
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
|
Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN
n=25 Participants
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
|
Group 16: LDV/SOF FDC 12 wk: GT 1, Fibrosis
n=10 Participants
LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
|
Group 17: LDV/SOF FDC+RBV 12 wk: GT 1, Fibrosis
n=9 Participants
LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
|
Group 18: LDV/SOF FDC 12 wk: GT 2 or 3, TN
n=10 Participants
LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
|
Group 20: LDV/SOF FDC+RBV 12 wk: GT 1, Hemophiliac
n=14 Participants
LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in hemophiliac participants with genotype 1 HCV infection
|
Group 21: LDV/SOF FDC+RBV 6 wk: GT 1, TN
n=25 Participants
LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 6 weeks in treatment-naive participants with genotype 1 HCV infection
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With HCV RNA < LOD at Week 6
|
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
|
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
|
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
|
100.0 percentage of participants
|
100.0 percentage of participants
|
SECONDARY outcome
Timeframe: Week 8Population: Participants in the Safety Analysis Set with available data were analyzed.
Data are not presented for Group 21 which ended treatment after Week 6.
Outcome measures
| Measure |
Group 5: SOF 12 wk: GT 2 or 3, TN
n=10 Participants
SOF 400 mg once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
|
Group 6: SOF+RBV+PEG 8 wk: GT 2 or 3, TN
n=10 Participants
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
|
Group 7: SOF+RBV 12 wk: GT 1, TE
n=10 Participants
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection who did not respond to prior treatment
|
Group 1: SOF+RBV 12 wk: GT 2 or 3, TN
n=10 Participants
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive (TN) participants with genotype (GT) 2 or 3 HCV infection
|
Group 2: SOF+RBV 12 wk +PEG 4 wk: GT 2 or 3, TN
n=9 Participants
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 4 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
|
Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN
n=10 Participants
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
|
Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN
n=11 Participants
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
|
Group 8: SOF+RBV 12 wk: GT 1, TN
n=25 Participants
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 1 HCV infection
|
Group 9: SOF+RBV 12 wk: GT 2 or 3, TE
n=25 Participants
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 2 or 3 HCV infection
|
Group 10: SOF+RBV 8 wk: GT 2 or 3, TN
n=25 Participants
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
|
Group 11: SOF+RBV 12 wk: GT 2 or 3, TN
n=10 Participants
SOF 400 mg once daily plus split-dose RBV (800 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
|
Group 12: SOF+RBV+LDV 12 wk: GT 1, TE
n=9 Participants
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
|
Group 13: SOF+RBV+LDV 12 wk: GT 1, TN
n=25 Participants
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
|
Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE
n=10 Participants
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
|
Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN
n=25 Participants
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
|
Group 16: LDV/SOF FDC 12 wk: GT 1, Fibrosis
n=10 Participants
LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
|
Group 17: LDV/SOF FDC+RBV 12 wk: GT 1, Fibrosis
n=9 Participants
LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
|
Group 18: LDV/SOF FDC 12 wk: GT 2 or 3, TN
n=10 Participants
LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
|
Group 20: LDV/SOF FDC+RBV 12 wk: GT 1, Hemophiliac
n=14 Participants
LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in hemophiliac participants with genotype 1 HCV infection
|
Group 21: LDV/SOF FDC+RBV 6 wk: GT 1, TN
LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 6 weeks in treatment-naive participants with genotype 1 HCV infection
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With HCV RNA < LOD at Week 8
|
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
|
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
|
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
|
100.0 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Week 12Population: Participants in the Safety Analysis Set with available data were analyzed.
Data are not presented for Groups 6, 10, and 21 which ended treatment after Week 8 or Week 6.
Outcome measures
| Measure |
Group 5: SOF 12 wk: GT 2 or 3, TN
n=10 Participants
SOF 400 mg once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
|
Group 6: SOF+RBV+PEG 8 wk: GT 2 or 3, TN
n=10 Participants
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
|
Group 7: SOF+RBV 12 wk: GT 1, TE
n=25 Participants
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection who did not respond to prior treatment
|
Group 1: SOF+RBV 12 wk: GT 2 or 3, TN
n=10 Participants
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive (TN) participants with genotype (GT) 2 or 3 HCV infection
|
Group 2: SOF+RBV 12 wk +PEG 4 wk: GT 2 or 3, TN
n=9 Participants
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 4 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
|
Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN
n=10 Participants
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
|
Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN
n=11 Participants
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
|
Group 8: SOF+RBV 12 wk: GT 1, TN
n=25 Participants
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 1 HCV infection
|
Group 9: SOF+RBV 12 wk: GT 2 or 3, TE
n=10 Participants
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 2 or 3 HCV infection
|
Group 10: SOF+RBV 8 wk: GT 2 or 3, TN
n=9 Participants
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
|
Group 11: SOF+RBV 12 wk: GT 2 or 3, TN
n=24 Participants
SOF 400 mg once daily plus split-dose RBV (800 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
|
Group 12: SOF+RBV+LDV 12 wk: GT 1, TE
n=10 Participants
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
|
Group 13: SOF+RBV+LDV 12 wk: GT 1, TN
n=25 Participants
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
|
Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE
n=10 Participants
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
|
Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN
n=9 Participants
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
|
Group 16: LDV/SOF FDC 12 wk: GT 1, Fibrosis
n=10 Participants
LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
|
Group 17: LDV/SOF FDC+RBV 12 wk: GT 1, Fibrosis
n=14 Participants
LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
|
Group 18: LDV/SOF FDC 12 wk: GT 2 or 3, TN
LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
|
Group 20: LDV/SOF FDC+RBV 12 wk: GT 1, Hemophiliac
LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in hemophiliac participants with genotype 1 HCV infection
|
Group 21: LDV/SOF FDC+RBV 6 wk: GT 1, TN
LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 6 weeks in treatment-naive participants with genotype 1 HCV infection
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With HCV RNA < LOD at Week 12
|
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
|
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
|
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
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 6Population: Safety Analysis Set
Outcome measures
| Measure |
Group 5: SOF 12 wk: GT 2 or 3, TN
n=10 Participants
SOF 400 mg once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
|
Group 6: SOF+RBV+PEG 8 wk: GT 2 or 3, TN
n=10 Participants
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
|
Group 7: SOF+RBV 12 wk: GT 1, TE
n=10 Participants
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection who did not respond to prior treatment
|
Group 1: SOF+RBV 12 wk: GT 2 or 3, TN
n=10 Participants
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive (TN) participants with genotype (GT) 2 or 3 HCV infection
|
Group 2: SOF+RBV 12 wk +PEG 4 wk: GT 2 or 3, TN
n=9 Participants
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 4 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
|
Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN
n=10 Participants
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
|
Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN
n=11 Participants
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
|
Group 8: SOF+RBV 12 wk: GT 1, TN
n=25 Participants
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 1 HCV infection
|
Group 9: SOF+RBV 12 wk: GT 2 or 3, TE
n=25 Participants
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 2 or 3 HCV infection
|
Group 10: SOF+RBV 8 wk: GT 2 or 3, TN
n=25 Participants
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
|
Group 11: SOF+RBV 12 wk: GT 2 or 3, TN
n=10 Participants
SOF 400 mg once daily plus split-dose RBV (800 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
|
Group 12: SOF+RBV+LDV 12 wk: GT 1, TE
n=9 Participants
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
|
Group 13: SOF+RBV+LDV 12 wk: GT 1, TN
n=25 Participants
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
|
Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE
n=10 Participants
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
|
Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN
n=25 Participants
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
|
Group 16: LDV/SOF FDC 12 wk: GT 1, Fibrosis
n=10 Participants
LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
|
Group 17: LDV/SOF FDC+RBV 12 wk: GT 1, Fibrosis
n=9 Participants
LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
|
Group 18: LDV/SOF FDC 12 wk: GT 2 or 3, TN
n=10 Participants
LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
|
Group 20: LDV/SOF FDC+RBV 12 wk: GT 1, Hemophiliac
n=14 Participants
LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in hemophiliac participants with genotype 1 HCV infection
|
Group 21: LDV/SOF FDC+RBV 6 wk: GT 1, TN
n=25 Participants
LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 6 weeks in treatment-naive participants with genotype 1 HCV infection
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in HCV RNA at Week 6
|
-6.23 log10 IU/mL
Standard Deviation 0.892
|
-4.94 log10 IU/mL
Standard Deviation 0.885
|
-5.70 log10 IU/mL
Standard Deviation 0.550
|
-5.52 log10 IU/mL
Standard Deviation 0.418
|
-5.44 log10 IU/mL
Standard Deviation 0.519
|
-5.23 log10 IU/mL
Standard Deviation 0.571
|
-5.20 log10 IU/mL
Standard Deviation 0.756
|
-4.95 log10 IU/mL
Standard Deviation 0.746
|
-5.38 log10 IU/mL
Standard Deviation 0.660
|
-4.92 log10 IU/mL
Standard Deviation 0.803
|
-5.01 log10 IU/mL
Standard Deviation 0.962
|
-5.74 log10 IU/mL
Standard Deviation 0.203
|
-4.80 log10 IU/mL
Standard Deviation 0.851
|
-5.84 log10 IU/mL
Standard Deviation 0.383
|
-5.19 log10 IU/mL
Standard Deviation 0.536
|
-5.36 log10 IU/mL
Standard Deviation 0.575
|
-5.18 log10 IU/mL
Standard Deviation 0.781
|
-4.93 log10 IU/mL
Standard Deviation 0.942
|
-5.35 log10 IU/mL
Standard Deviation 0.510
|
-5.39 log10 IU/mL
Standard Deviation 0.559
|
SECONDARY outcome
Timeframe: Baseline to Week 8Population: Participants in the Safety Analysis Set with available data were analyzed.
Data are not presented for Group 21 which ended treatment after Week 6.
Outcome measures
| Measure |
Group 5: SOF 12 wk: GT 2 or 3, TN
n=10 Participants
SOF 400 mg once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
|
Group 6: SOF+RBV+PEG 8 wk: GT 2 or 3, TN
n=10 Participants
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
|
Group 7: SOF+RBV 12 wk: GT 1, TE
n=10 Participants
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection who did not respond to prior treatment
|
Group 1: SOF+RBV 12 wk: GT 2 or 3, TN
n=10 Participants
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive (TN) participants with genotype (GT) 2 or 3 HCV infection
|
Group 2: SOF+RBV 12 wk +PEG 4 wk: GT 2 or 3, TN
n=9 Participants
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 4 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
|
Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN
n=10 Participants
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
|
Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN
n=11 Participants
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
|
Group 8: SOF+RBV 12 wk: GT 1, TN
n=25 Participants
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 1 HCV infection
|
Group 9: SOF+RBV 12 wk: GT 2 or 3, TE
n=25 Participants
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 2 or 3 HCV infection
|
Group 10: SOF+RBV 8 wk: GT 2 or 3, TN
n=25 Participants
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
|
Group 11: SOF+RBV 12 wk: GT 2 or 3, TN
n=10 Participants
SOF 400 mg once daily plus split-dose RBV (800 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
|
Group 12: SOF+RBV+LDV 12 wk: GT 1, TE
n=9 Participants
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
|
Group 13: SOF+RBV+LDV 12 wk: GT 1, TN
n=25 Participants
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
|
Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE
n=10 Participants
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
|
Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN
n=25 Participants
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
|
Group 16: LDV/SOF FDC 12 wk: GT 1, Fibrosis
n=10 Participants
LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
|
Group 17: LDV/SOF FDC+RBV 12 wk: GT 1, Fibrosis
n=9 Participants
LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
|
Group 18: LDV/SOF FDC 12 wk: GT 2 or 3, TN
n=10 Participants
LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
|
Group 20: LDV/SOF FDC+RBV 12 wk: GT 1, Hemophiliac
n=14 Participants
LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in hemophiliac participants with genotype 1 HCV infection
|
Group 21: LDV/SOF FDC+RBV 6 wk: GT 1, TN
LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 6 weeks in treatment-naive participants with genotype 1 HCV infection
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in HCV RNA at Week 8
|
-4.59 log10 IU/mL
Standard Deviation 0.892
|
-4.94 log10 IU/mL
Standard Deviation 0.885
|
-5.70 log10 IU/mL
Standard Deviation 0.550
|
-5.52 log10 IU/mL
Standard Deviation 0.418
|
-5.44 log10 IU/mL
Standard Deviation 0.519
|
-5.23 log10 IU/mL
Standard Deviation 0.571
|
-5.20 log10 IU/mL
Standard Deviation 0.756
|
-4.95 log10 IU/mL
Standard Deviation 0.746
|
-5.38 log10 IU/mL
Standard Deviation 0.660
|
-4.92 log10 IU/mL
Standard Deviation 0.803
|
-5.01 log10 IU/mL
Standard Deviation 0.962
|
-5.74 log10 IU/mL
Standard Deviation 0.203
|
-4.80 log10 IU/mL
Standard Deviation 0.851
|
-5.84 log10 IU/mL
Standard Deviation 0.383
|
-5.19 log10 IU/mL
Standard Deviation 0.536
|
-5.36 log10 IU/mL
Standard Deviation 0.575
|
-5.18 log10 IU/mL
Standard Deviation 0.781
|
-4.93 log10 IU/mL
Standard Deviation 0.942
|
-5.35 log10 IU/mL
Standard Deviation 0.510
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: Participants in the Safety Analysis Set with available data were analyzed.
Data are not presented for Groups 6, 10, and 21 which ended treatment after Week 8 or Week 6. Data are not presented for Groups 16, 17, 18, and 20 because participants with detectable HCV RNA discontinued due to protocol-specified stopping rules.
Outcome measures
| Measure |
Group 5: SOF 12 wk: GT 2 or 3, TN
n=10 Participants
SOF 400 mg once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
|
Group 6: SOF+RBV+PEG 8 wk: GT 2 or 3, TN
n=10 Participants
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
|
Group 7: SOF+RBV 12 wk: GT 1, TE
n=25 Participants
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection who did not respond to prior treatment
|
Group 1: SOF+RBV 12 wk: GT 2 or 3, TN
n=10 Participants
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive (TN) participants with genotype (GT) 2 or 3 HCV infection
|
Group 2: SOF+RBV 12 wk +PEG 4 wk: GT 2 or 3, TN
n=9 Participants
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 4 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
|
Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN
n=10 Participants
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
|
Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN
n=11 Participants
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
|
Group 8: SOF+RBV 12 wk: GT 1, TN
n=25 Participants
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 1 HCV infection
|
Group 9: SOF+RBV 12 wk: GT 2 or 3, TE
n=10 Participants
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 2 or 3 HCV infection
|
Group 10: SOF+RBV 8 wk: GT 2 or 3, TN
n=9 Participants
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
|
Group 11: SOF+RBV 12 wk: GT 2 or 3, TN
n=24 Participants
SOF 400 mg once daily plus split-dose RBV (800 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
|
Group 12: SOF+RBV+LDV 12 wk: GT 1, TE
n=10 Participants
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
|
Group 13: SOF+RBV+LDV 12 wk: GT 1, TN
n=25 Participants
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
|
Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
|
Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
|
Group 16: LDV/SOF FDC 12 wk: GT 1, Fibrosis
LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
|
Group 17: LDV/SOF FDC+RBV 12 wk: GT 1, Fibrosis
LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
|
Group 18: LDV/SOF FDC 12 wk: GT 2 or 3, TN
LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
|
Group 20: LDV/SOF FDC+RBV 12 wk: GT 1, Hemophiliac
LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in hemophiliac participants with genotype 1 HCV infection
|
Group 21: LDV/SOF FDC+RBV 6 wk: GT 1, TN
LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 6 weeks in treatment-naive participants with genotype 1 HCV infection
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in HCV RNA at Week 12
|
-4.59 log10 IU/mL
Standard Deviation 0.892
|
-5.70 log10 IU/mL
Standard Deviation 0.550
|
-4.95 log10 IU/mL
Standard Deviation 0.746
|
-5.52 log10 IU/mL
Standard Deviation 0.418
|
-5.44 log10 IU/mL
Standard Deviation 0.519
|
-5.23 log10 IU/mL
Standard Deviation 0.571
|
-5.20 log10 IU/mL
Standard Deviation 0.756
|
-5.39 log10 IU/mL
Standard Deviation 0.660
|
-2.01 log10 IU/mL
Standard Deviation 0.962
|
-5.74 log10 IU/mL
Standard Deviation 0.203
|
-4.85 log10 IU/mL
Standard Deviation 0.823
|
-5.84 log10 IU/mL
Standard Deviation 0.383
|
-5.19 log10 IU/mL
Standard Deviation 0.536
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Posttreatment Week 24Population: Safety Analysis Set
The percentage of participants with on-treatment virologic failure (viral breakthrough, rebound, or nonresponse) or following treatment (viral relapse) was summarized. On-treatment virologic failure was defined as: * Viral breakthrough (confirmed HCV RNA ≥ LOD after having previously had HCV RNA \< LOD while on treatment), * Viral rebound (confirmed \> 1 log10 IU/mL increase in HCV RNA from nadir while on treatment, or * Nonresponse (HCV RNA persistently ≥ LOD through 6 weeks of treatment) Viral relapse was defined as confirmed HCV RNA ≥ LOD during the posttreatment period having achieved HCV RNA \< LOD at the last on-treatment visit.
Outcome measures
| Measure |
Group 5: SOF 12 wk: GT 2 or 3, TN
n=10 Participants
SOF 400 mg once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
|
Group 6: SOF+RBV+PEG 8 wk: GT 2 or 3, TN
n=10 Participants
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
|
Group 7: SOF+RBV 12 wk: GT 1, TE
n=10 Participants
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection who did not respond to prior treatment
|
Group 1: SOF+RBV 12 wk: GT 2 or 3, TN
n=10 Participants
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive (TN) participants with genotype (GT) 2 or 3 HCV infection
|
Group 2: SOF+RBV 12 wk +PEG 4 wk: GT 2 or 3, TN
n=9 Participants
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 4 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
|
Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN
n=10 Participants
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
|
Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN
n=11 Participants
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
|
Group 8: SOF+RBV 12 wk: GT 1, TN
n=25 Participants
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 1 HCV infection
|
Group 9: SOF+RBV 12 wk: GT 2 or 3, TE
n=25 Participants
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 2 or 3 HCV infection
|
Group 10: SOF+RBV 8 wk: GT 2 or 3, TN
n=25 Participants
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
|
Group 11: SOF+RBV 12 wk: GT 2 or 3, TN
n=10 Participants
SOF 400 mg once daily plus split-dose RBV (800 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
|
Group 12: SOF+RBV+LDV 12 wk: GT 1, TE
n=9 Participants
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
|
Group 13: SOF+RBV+LDV 12 wk: GT 1, TN
n=25 Participants
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
|
Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE
n=10 Participants
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
|
Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN
n=25 Participants
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
|
Group 16: LDV/SOF FDC 12 wk: GT 1, Fibrosis
n=10 Participants
LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
|
Group 17: LDV/SOF FDC+RBV 12 wk: GT 1, Fibrosis
n=9 Participants
LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
|
Group 18: LDV/SOF FDC 12 wk: GT 2 or 3, TN
n=10 Participants
LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
|
Group 20: LDV/SOF FDC+RBV 12 wk: GT 1, Hemophiliac
n=14 Participants
LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in hemophiliac participants with genotype 1 HCV infection
|
Group 21: LDV/SOF FDC+RBV 6 wk: GT 1, TN
n=25 Participants
LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 6 weeks in treatment-naive participants with genotype 1 HCV infection
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Virologic Failure
On-treatment virologic failure
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With Virologic Failure
Viral relapse
|
40.0 percentage of participants
|
0.0 percentage of participants
|
90.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
16.0 percentage of participants
|
32.0 percentage of participants
|
36.0 percentage of participants
|
40.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
8.0 percentage of participants
|
30.0 percentage of participants
|
0.0 percentage of participants
|
20.0 percentage of participants
|
0.0 percentage of participants
|
32.0 percentage of participants
|
Adverse Events
Group 1: SOF+RBV 12 wk: GT 2 or 3, TN
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Group 2: SOF+RBV 12 wk +PEG 4 wk: GT 2 or 3, TN
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Group 5: SOF 12 wk: GT 2 or 3, TN
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Group 6: SOF+RBV+PEG 8 wk: GT 2 or 3, TN
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Group 7: SOF+RBV 12 wk: GT 1, TE
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Group 8: SOF+RBV 12 wk: GT 1, TN
Serious events: 1 serious events
Other events: 25 other events
Deaths: 0 deaths
Group 9: SOF+RBV 12 wk: GT 2 or 3, TE
Serious events: 0 serious events
Other events: 24 other events
Deaths: 0 deaths
Group 10: SOF+RBV 8 wk: GT 2 or 3, TN
Serious events: 2 serious events
Other events: 25 other events
Deaths: 0 deaths
Group 11: SOF+RBV 12 wk: GT 2 or 3, TN
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Group 12: SOF+RBV+LDV 12 wk: GT 1, TE
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Group 13: SOF+RBV+LDV 12 wk: GT 1, TN
Serious events: 2 serious events
Other events: 24 other events
Deaths: 0 deaths
Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN
Serious events: 0 serious events
Other events: 25 other events
Deaths: 0 deaths
Group 16: LDV/SOF FDC 12 wk: GT 1, Fibrosis
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Group 17: LDV/SOF FDC+RBV 12 wk: GT 1, Fibrosis
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Group 18: LDV/SOF FDC 12 wk: GT 2 or 3, TN
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Group 20: LDV/SOF FDC+RBV 12 wk: GT 1, Hemophiliac
Serious events: 2 serious events
Other events: 13 other events
Deaths: 0 deaths
Group 21: LDV/SOF FDC+RBV 6 wk: GT 1, TN
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1: SOF+RBV 12 wk: GT 2 or 3, TN
n=10 participants at risk
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive (TN) participants with genotype (GT) 2 or 3 HCV infection
|
Group 2: SOF+RBV 12 wk +PEG 4 wk: GT 2 or 3, TN
n=9 participants at risk
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 4 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
|
Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN
n=10 participants at risk
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
|
Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN
n=11 participants at risk
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
|
Group 5: SOF 12 wk: GT 2 or 3, TN
n=10 participants at risk
SOF 400 mg once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
|
Group 6: SOF+RBV+PEG 8 wk: GT 2 or 3, TN
n=10 participants at risk
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
|
Group 7: SOF+RBV 12 wk: GT 1, TE
n=10 participants at risk
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection who did not respond to prior treatment
|
Group 8: SOF+RBV 12 wk: GT 1, TN
n=25 participants at risk
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 1 HCV infection
|
Group 9: SOF+RBV 12 wk: GT 2 or 3, TE
n=25 participants at risk
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 2 or 3 HCV infection
|
Group 10: SOF+RBV 8 wk: GT 2 or 3, TN
n=25 participants at risk
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
|
Group 11: SOF+RBV 12 wk: GT 2 or 3, TN
n=10 participants at risk
SOF 400 mg once daily plus split-dose RBV (800 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
|
Group 12: SOF+RBV+LDV 12 wk: GT 1, TE
n=9 participants at risk
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
|
Group 13: SOF+RBV+LDV 12 wk: GT 1, TN
n=25 participants at risk
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
|
Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE
n=10 participants at risk
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
|
Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN
n=25 participants at risk
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
|
Group 16: LDV/SOF FDC 12 wk: GT 1, Fibrosis
n=10 participants at risk
LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
|
Group 17: LDV/SOF FDC+RBV 12 wk: GT 1, Fibrosis
n=9 participants at risk
LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
|
Group 18: LDV/SOF FDC 12 wk: GT 2 or 3, TN
n=10 participants at risk
LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
|
Group 20: LDV/SOF FDC+RBV 12 wk: GT 1, Hemophiliac
n=14 participants at risk
LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in hemophiliac participants with genotype 1 HCV infection
|
Group 21: LDV/SOF FDC+RBV 6 wk: GT 1, TN
n=25 participants at risk
LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 6 weeks in treatment-naive participants with genotype 1 HCV infection
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Angina Pectoris
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Gastrointestinal disorders
Diverticulitis Perforation
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
4.0%
1/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Gastrointestinal disorders
Emterovesical Fistula
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
4.0%
1/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
7.1%
1/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Infections and infestations
Breast Abscess
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
4.0%
1/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
4.0%
1/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Infections and infestations
Furuncle
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
4.0%
1/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Injury, poisoning and procedural complications
Urethral injury
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
4.0%
1/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Syncope
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
7.1%
1/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
4.0%
1/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
Other adverse events
| Measure |
Group 1: SOF+RBV 12 wk: GT 2 or 3, TN
n=10 participants at risk
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive (TN) participants with genotype (GT) 2 or 3 HCV infection
|
Group 2: SOF+RBV 12 wk +PEG 4 wk: GT 2 or 3, TN
n=9 participants at risk
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 4 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
|
Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN
n=10 participants at risk
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
|
Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN
n=11 participants at risk
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
|
Group 5: SOF 12 wk: GT 2 or 3, TN
n=10 participants at risk
SOF 400 mg once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
|
Group 6: SOF+RBV+PEG 8 wk: GT 2 or 3, TN
n=10 participants at risk
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
|
Group 7: SOF+RBV 12 wk: GT 1, TE
n=10 participants at risk
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection who did not respond to prior treatment
|
Group 8: SOF+RBV 12 wk: GT 1, TN
n=25 participants at risk
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 1 HCV infection
|
Group 9: SOF+RBV 12 wk: GT 2 or 3, TE
n=25 participants at risk
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 2 or 3 HCV infection
|
Group 10: SOF+RBV 8 wk: GT 2 or 3, TN
n=25 participants at risk
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
|
Group 11: SOF+RBV 12 wk: GT 2 or 3, TN
n=10 participants at risk
SOF 400 mg once daily plus split-dose RBV (800 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
|
Group 12: SOF+RBV+LDV 12 wk: GT 1, TE
n=9 participants at risk
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
|
Group 13: SOF+RBV+LDV 12 wk: GT 1, TN
n=25 participants at risk
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
|
Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE
n=10 participants at risk
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
|
Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN
n=25 participants at risk
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
|
Group 16: LDV/SOF FDC 12 wk: GT 1, Fibrosis
n=10 participants at risk
LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
|
Group 17: LDV/SOF FDC+RBV 12 wk: GT 1, Fibrosis
n=9 participants at risk
LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
|
Group 18: LDV/SOF FDC 12 wk: GT 2 or 3, TN
n=10 participants at risk
LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
|
Group 20: LDV/SOF FDC+RBV 12 wk: GT 1, Hemophiliac
n=14 participants at risk
LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in hemophiliac participants with genotype 1 HCV infection
|
Group 21: LDV/SOF FDC+RBV 6 wk: GT 1, TN
n=25 participants at risk
LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 6 weeks in treatment-naive participants with genotype 1 HCV infection
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
General disorders
Pyrexia
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
11.1%
1/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
18.2%
2/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
50.0%
5/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
4.0%
1/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
General disorders
Feeling of body temperature change
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
9.1%
1/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Skin and subcutaneous tissue disorders
Macule
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
9.1%
1/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
4.0%
1/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
4.0%
1/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
8.0%
2/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Musculoskeletal and connective tissue disorders
Upper extremity mass
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
General disorders
Influenza like illness
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
General disorders
Injection site discomfort
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
9.1%
1/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
General disorders
Injection site erythema
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
9.1%
1/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
20.0%
2/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
General disorders
Injection site inflammation
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
9.1%
1/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
General disorders
Injection site pain
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
General disorders
Injection site reaction
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
General disorders
Irritability
|
20.0%
2/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
36.4%
4/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
20.0%
2/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
20.0%
5/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
12.0%
3/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
11.1%
1/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
16.0%
4/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
4.0%
1/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
14.3%
2/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
12.0%
3/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
General disorders
Malaise
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
11.1%
1/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
9.1%
1/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
4.0%
1/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
General disorders
Oedema peripheral
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
9.1%
1/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
General disorders
Pain
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
9.1%
1/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
20.0%
2/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
11.1%
1/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Blood and lymphatic system disorders
Anaemia
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
33.3%
3/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
18.2%
2/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
30.0%
3/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
20.0%
2/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
4.0%
1/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
12.0%
3/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
4.0%
1/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
14.3%
2/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Blood and lymphatic system disorders
Haemolytic anaemia
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
11.1%
1/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
9.1%
1/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
20.0%
5/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
4.0%
1/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
8.0%
2/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
12.0%
3/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
12.0%
3/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
7.1%
1/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
8.0%
2/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
11.1%
1/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
8.0%
2/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
11.1%
1/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
11.1%
1/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
18.2%
2/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
8.0%
2/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Ear and labyrinth disorders
Ear discomfort
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
7.1%
1/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Ear and labyrinth disorders
Eustachian tube obstruction
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Ear and labyrinth disorders
Tinnitus
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Eye disorders
Blepharitis
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
11.1%
1/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
4.0%
1/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
7.1%
1/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
4.0%
1/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Eye disorders
Blepharospasm
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
9.1%
1/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
22.2%
2/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
7.1%
1/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Eye disorders
Dry eye
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
20.0%
2/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
4.0%
1/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Eye disorders
Eye inflammation
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
11.1%
1/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Eye disorders
Eye irritation
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
9.1%
1/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Eye disorders
Eye pain
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
11.1%
1/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
11.1%
1/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Eye disorders
Ocular discomfort
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Eye disorders
Photophobia
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
9.1%
1/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
4.0%
1/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Eye disorders
Pterygium
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Eye disorders
Vision blurred
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
9.1%
1/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
4.0%
1/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
4.0%
1/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Eye disorders
Visual impairment
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
9.1%
1/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
4.0%
1/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
4.0%
1/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
11.1%
1/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
20.0%
2/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
4.0%
1/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
4.0%
1/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
11.1%
1/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
8.0%
2/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
8.0%
2/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
11.1%
1/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
4.0%
1/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
9.1%
1/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
4.0%
1/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
4.0%
1/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
7.1%
1/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
11.1%
1/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
4.0%
1/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
8.0%
2/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
4.0%
1/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Gastrointestinal disorders
Anal fissure
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
11.1%
1/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
9.1%
1/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Gastrointestinal disorders
Anal pruritus
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
7.1%
1/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
4.0%
1/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
11.1%
1/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
7.1%
1/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
8.0%
2/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Gastrointestinal disorders
Change of bowel habit
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
11.1%
1/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Gastrointestinal disorders
Chapped lips
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
11.1%
1/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Gastrointestinal disorders
Cheilitis
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
11.1%
1/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
4.0%
1/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
12.0%
3/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
12.0%
3/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
4.0%
1/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
7.1%
1/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
8.0%
2/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
4.0%
1/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Gastrointestinal disorders
Diarrhoea
|
20.0%
2/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
20.0%
2/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
18.2%
2/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
30.0%
3/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
24.0%
6/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
4.0%
1/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
12.0%
3/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
11.1%
1/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
8.0%
2/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
16.0%
4/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
30.0%
3/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
4.0%
1/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
20.0%
2/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
7.1%
1/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
11.1%
1/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
9.1%
1/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
4.0%
1/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
8.0%
2/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
11.1%
1/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
12.0%
3/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
7.1%
1/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
4.0%
1/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
20.0%
2/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
4.0%
1/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
7.1%
1/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Gastrointestinal disorders
Frequent bowel movements
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
9.1%
1/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
4.0%
1/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
12.0%
3/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
8.0%
2/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
4.0%
1/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
22.2%
2/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
4.0%
1/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
4.0%
1/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
22.2%
2/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
7.1%
1/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Gastrointestinal disorders
Gingival disorder
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
9.1%
1/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Gastrointestinal disorders
Gingival ulceration
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
9.1%
1/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Gastrointestinal disorders
Glossodynia
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
11.1%
1/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
9.1%
1/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
33.3%
3/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
40.0%
4/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
18.2%
2/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
30.0%
3/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
20.0%
2/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
20.0%
2/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
44.0%
11/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
20.0%
5/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
16.0%
4/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
30.0%
3/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
33.3%
3/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
24.0%
6/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
20.0%
2/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
36.0%
9/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
44.4%
4/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
28.6%
4/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
20.0%
5/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Gastrointestinal disorders
Paraesthesia oral
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Gastrointestinal disorders
Stomatitis haemorrhagic
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
7.1%
1/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
9.1%
1/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
8.0%
2/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
4.0%
1/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
11.1%
1/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
22.2%
2/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
8.0%
2/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
4.0%
1/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
8.0%
2/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
11.1%
1/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
4.0%
1/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
36.0%
9/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
22.2%
2/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
7.1%
1/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
12.0%
3/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
General disorders
Application site inflammation
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
General disorders
Asthenia
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
11.1%
1/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
General disorders
Axillary pain
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
20.0%
2/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
General disorders
Catheter site pain
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
General disorders
Chest discomfort
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
7.1%
1/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
General disorders
Chest pain
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
4.0%
1/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
11.1%
1/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
11.1%
1/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
General disorders
Chills
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
22.2%
2/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
20.0%
2/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
General disorders
Crying
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
9.1%
1/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
General disorders
Drug withdrawal syndrome
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
General disorders
Facial pain
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
11.1%
1/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
General disorders
Fatigue
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
33.3%
3/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
30.0%
3/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
45.5%
5/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
30.0%
3/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
70.0%
7/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
40.0%
4/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
48.0%
12/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
40.0%
10/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
36.0%
9/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
77.8%
7/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
24.0%
6/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
50.0%
5/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
16.0%
4/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
11.1%
1/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
50.0%
7/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
24.0%
6/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
General disorders
Feeling abnormal
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
General disorders
Feeling cold
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
18.2%
2/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
General disorders
Spinal pain
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
General disorders
Thirst
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
General disorders
Vessel puncture site bruise
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
4.0%
1/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
8.0%
2/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
General disorders
Vessel puncture site pain
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Hepatobiliary disorders
Biliary colic
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
7.1%
1/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
7.1%
1/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
9.1%
1/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
11.1%
1/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Infections and infestations
Conjunctivitis viral
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
9.1%
1/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
8.0%
2/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Infections and infestations
Furuncle
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
11.1%
1/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
4.0%
1/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
22.2%
2/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Infections and infestations
Gingivitis
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
11.1%
1/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
4.0%
1/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Infections and infestations
Groin abscess
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
11.1%
1/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
11.1%
1/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
4.0%
1/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Infections and infestations
Herpes zoster
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Infections and infestations
Hordeolum
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
9.1%
1/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Infections and infestations
Infective exacerbation of bronchiectasis
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
11.1%
1/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
9.1%
1/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
8.0%
2/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
4.0%
1/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
8.0%
2/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Infections and infestations
Otitis externa
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
11.1%
1/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
9.1%
1/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
7.1%
1/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Infections and infestations
Otitis media
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
4.0%
1/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
4.0%
1/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
8.0%
2/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Infections and infestations
Pilonidal cyst
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
7.1%
1/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Infections and infestations
Rash pustular
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
9.1%
1/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
4.0%
1/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
4.0%
1/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Infections and infestations
Respiratory tract infection
|
20.0%
2/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
11.1%
1/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
9.1%
1/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
16.0%
4/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
4.0%
1/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Infections and infestations
Rhinitis
|
20.0%
2/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
20.0%
2/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
8.0%
2/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
4.0%
1/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
11.1%
1/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
8.0%
2/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
12.0%
3/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
4.0%
1/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
11.1%
1/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Infections and infestations
Tinea pedis
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
11.1%
1/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
11.1%
1/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
9.1%
1/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
20.0%
2/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
16.0%
4/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
24.0%
6/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
12.0%
3/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
30.0%
3/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
33.3%
3/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
36.0%
9/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
20.0%
2/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
12.0%
3/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
11.1%
1/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
20.0%
2/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
14.3%
2/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
12.0%
3/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Infections and infestations
Urinary tract infection
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
18.2%
2/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
8.0%
2/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Infections and infestations
Viral infection
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
4.0%
1/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Infections and infestations
Vulvovaginal candidiasis
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Infections and infestations
Vulvovaginitis trichomonal
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Injury, poisoning and procedural complications
Animal scratch
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
11.1%
1/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
11.1%
1/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
11.1%
1/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Injury, poisoning and procedural complications
Chest injury
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Injury, poisoning and procedural complications
Contusion
|
20.0%
2/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
12.0%
3/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
4.0%
1/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
7.1%
1/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Injury, poisoning and procedural complications
Excoriation
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
11.1%
1/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
22.2%
2/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
4.0%
1/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
4.0%
1/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
11.1%
1/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
4.0%
1/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
7.1%
1/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Injury, poisoning and procedural complications
Nerve injury
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
9.1%
1/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Injury, poisoning and procedural complications
Peroneal nerve injury
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
11.1%
1/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
4.0%
1/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
4.0%
1/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Injury, poisoning and procedural complications
Vessel puncture site bruise
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Investigations
Haemoglobin decreased
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Investigations
Liver function test abnormal
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
7.1%
1/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Investigations
Weight decreased
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
9.1%
1/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
4.0%
1/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
8.0%
2/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Investigations
Weight increased
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Metabolism and nutrition disorders
Abnormal loss of weight
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
22.2%
2/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
27.3%
3/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
50.0%
5/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
8.0%
2/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
8.0%
2/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
12.0%
3/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
8.0%
2/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
8.0%
2/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Metabolism and nutrition disorders
Food craving
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
11.1%
1/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Metabolism and nutrition disorders
Increased appetite
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
11.1%
1/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
9.1%
1/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Metabolism and nutrition disorders
Polydipsia
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
11.1%
1/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
8.0%
2/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
11.1%
1/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
4.0%
1/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
11.1%
1/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
30.0%
3/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
9.1%
1/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
12.0%
3/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
8.0%
2/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
20.0%
5/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
20.0%
2/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
8.0%
2/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
22.2%
2/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
7.1%
1/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
4.0%
1/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
22.2%
2/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
9.1%
1/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
20.0%
2/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
8.0%
2/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
4.0%
1/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
8.0%
2/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
4.0%
1/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
8.0%
2/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Musculoskeletal and connective tissue disorders
Muscle atrophy
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
7.1%
1/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
20.0%
2/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
4.0%
1/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
8.0%
2/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
4.0%
1/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
11.1%
1/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
4.0%
1/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
9.1%
1/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
11.1%
1/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
4.0%
1/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
4.0%
1/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
4.0%
1/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
11.1%
1/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
8.0%
2/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
9.1%
1/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
8.0%
2/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
8.0%
2/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
22.2%
2/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
20.0%
2/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
18.2%
2/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
20.0%
2/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
33.3%
3/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
30.0%
3/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
27.3%
3/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
40.0%
4/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
8.0%
2/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
24.0%
6/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
33.3%
3/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
8.0%
2/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
9.1%
1/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
4.0%
1/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
4.0%
1/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
8.0%
2/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Nervous system disorders
Amnesia
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
11.1%
1/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
4.0%
1/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
11.1%
1/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Nervous system disorders
Balance disorder
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Nervous system disorders
Disturbance in attention
|
20.0%
2/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
11.1%
1/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
4.0%
1/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
4.0%
1/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
11.1%
1/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
8.0%
2/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
8.0%
2/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Nervous system disorders
Dizziness
|
40.0%
4/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
44.4%
4/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
20.0%
2/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
27.3%
3/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
20.0%
2/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
4.0%
1/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
4.0%
1/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
8.0%
2/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
22.2%
2/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
12.0%
3/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
4.0%
1/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
7.1%
1/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
20.0%
2/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Nervous system disorders
Dysgeusia
|
20.0%
2/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
4.0%
1/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
4.0%
1/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
7.1%
1/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Nervous system disorders
Head discomfort
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Nervous system disorders
Headache
|
40.0%
4/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
77.8%
7/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
90.0%
9/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
72.7%
8/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
80.0%
8/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
60.0%
6/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
40.0%
4/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
32.0%
8/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
44.0%
11/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
24.0%
6/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
20.0%
2/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
66.7%
6/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
44.0%
11/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
40.0%
4/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
32.0%
8/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
30.0%
3/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
22.2%
2/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
40.0%
4/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
35.7%
5/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
32.0%
8/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Nervous system disorders
Hyperaesthesia
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
8.0%
2/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Nervous system disorders
Hypogeusia
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Nervous system disorders
Lethargy
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
22.2%
2/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
20.0%
2/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
12.0%
3/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
16.0%
4/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
4.0%
1/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
12.0%
3/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
4.0%
1/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
20.0%
2/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
22.2%
2/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
7.1%
1/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
8.0%
2/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Nervous system disorders
Memory impairment
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Nervous system disorders
Migraine
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
11.1%
1/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
4.0%
1/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
11.1%
1/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
4.0%
1/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
4.0%
1/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
4.0%
1/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
11.1%
1/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
8.0%
2/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
4.0%
1/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
4.0%
1/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
11.1%
1/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
4.0%
1/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Nervous system disorders
Restless legs syndrome
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
8.0%
2/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Nervous system disorders
Syncope
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
8.0%
2/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
4.0%
1/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
4.0%
1/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Nervous system disorders
Tremor
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
4.0%
1/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Psychiatric disorders
Abnormal dreams
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
11.1%
1/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Psychiatric disorders
Affect lability
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
11.1%
1/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
4.0%
1/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Psychiatric disorders
Anxiety
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
22.2%
2/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
9.1%
1/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
8.0%
2/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
4.0%
1/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
11.1%
1/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
4.0%
1/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
22.2%
2/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
20.0%
2/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
4.0%
1/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Psychiatric disorders
Depressed mood
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
22.2%
2/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
18.2%
2/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
4.0%
1/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
8.0%
2/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
11.1%
1/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Psychiatric disorders
Depression
|
20.0%
2/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
11.1%
1/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
27.3%
3/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
8.0%
2/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
22.2%
2/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
16.0%
4/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
11.1%
1/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
7.1%
1/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Psychiatric disorders
Depressive symptom
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
11.1%
1/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Psychiatric disorders
Dysphoria
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Psychiatric disorders
Dysthymic disorder
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
11.1%
1/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Psychiatric disorders
Impatience
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
11.1%
1/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Psychiatric disorders
Insomnia
|
30.0%
3/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
66.7%
6/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
50.0%
5/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
45.5%
5/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
60.0%
6/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
40.0%
4/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
20.0%
5/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
12.0%
3/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
12.0%
3/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
20.0%
2/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
44.4%
4/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
16.0%
4/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
12.0%
3/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
11.1%
1/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
20.0%
2/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
21.4%
3/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
24.0%
6/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Psychiatric disorders
Libido decreased
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
11.1%
1/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Psychiatric disorders
Loss of libido
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
9.1%
1/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Psychiatric disorders
Mood altered
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
20.0%
2/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
8.0%
2/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Psychiatric disorders
Mood swings
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
9.1%
1/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Psychiatric disorders
Panic attack
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
4.0%
1/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
11.1%
1/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
9.1%
1/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
4.0%
1/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
11.1%
1/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Renal and urinary disorders
Chromaturia
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
11.1%
1/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
11.1%
1/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
7.1%
1/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
4.0%
1/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
12.0%
3/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
11.1%
1/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
7.1%
1/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Renal and urinary disorders
Micturition urgency
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
11.1%
1/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
11.1%
1/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
11.1%
1/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
4.0%
1/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
11.1%
1/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Renal and urinary disorders
Polyuria
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
8.0%
2/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
4.0%
1/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Renal and urinary disorders
Urine odour abnormal
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
11.1%
1/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Reproductive system and breast disorders
Amenorrhoea
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
9.1%
1/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Reproductive system and breast disorders
Cervical dysplasia
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
9.1%
1/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
11.1%
1/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Reproductive system and breast disorders
Menstruation delayed
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
11.1%
1/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
11.1%
1/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
11.1%
1/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
4.0%
1/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
11.1%
1/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
20.0%
2/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
11.1%
1/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
4.0%
1/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
4.0%
1/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
33.3%
3/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
12.0%
3/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
4.0%
1/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
4.0%
1/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
36.4%
4/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
4.0%
1/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
4.0%
1/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
16.0%
4/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
16.0%
4/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
11.1%
1/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
7.1%
1/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
18.2%
2/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
4.0%
1/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
11.1%
1/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
4.0%
1/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
4.0%
1/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
14.3%
2/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
4.0%
1/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
9.1%
1/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
11.1%
1/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
8.0%
2/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
7.1%
1/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Respiratory, thoracic and mediastinal disorders
Increased upper airway secretion
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
11.1%
1/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
20.0%
2/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
9.1%
1/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
4.0%
1/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
4.0%
1/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
11.1%
1/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
20.0%
2/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
11.1%
1/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
9.1%
1/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
20.0%
2/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
8.0%
2/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
33.3%
3/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
8.0%
2/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
4.0%
1/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
12.0%
3/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal erythema
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
9.1%
1/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
8.0%
2/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
11.1%
1/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract congestion
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
11.1%
1/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
50.0%
5/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
9.1%
1/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
4.0%
1/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
11.1%
1/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
4.0%
1/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
4.0%
1/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Skin and subcutaneous tissue disorders
Catheter site bruise
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Skin and subcutaneous tissue disorders
Cold sweat
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
4.0%
1/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
11.1%
1/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
40.0%
4/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
20.0%
2/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
4.0%
1/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
16.0%
4/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
4.0%
1/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
11.1%
1/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
20.0%
5/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
8.0%
2/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
11.1%
1/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
4.0%
1/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
4.0%
1/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
8.0%
2/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
22.2%
2/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
4.0%
1/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Skin and subcutaneous tissue disorders
Onychoclasis
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
33.3%
3/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
30.0%
3/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
18.2%
2/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
20.0%
2/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
20.0%
2/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
4.0%
1/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
8.0%
2/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
20.0%
2/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
8.0%
2/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
12.0%
3/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
7.1%
1/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
7.1%
1/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
9.1%
1/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Skin and subcutaneous tissue disorders
Rash
|
30.0%
3/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
33.3%
3/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
30.0%
3/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
27.3%
3/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
60.0%
6/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
30.0%
3/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
16.0%
4/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
24.0%
6/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
4.0%
1/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
11.1%
1/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
16.0%
4/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
20.0%
5/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
7.1%
1/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
12.0%
3/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
9.1%
1/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
4.0%
1/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
11.1%
1/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
4.0%
1/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
11.1%
1/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
9.1%
1/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
9.1%
1/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
4.0%
1/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
22.2%
2/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
9.1%
1/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
4.0%
1/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Surgical and medical procedures
Tooth extraction
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
4.0%
1/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Vascular disorders
Haematoma
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Vascular disorders
Hot flush
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
11.1%
1/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
20.0%
2/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
11.1%
1/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
7.1%
1/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Vascular disorders
Hypertension
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
4.0%
1/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
|
Vascular disorders
Thrombophlebitis superficial
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/11 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
10.0%
1/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/9 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/10 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/14 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
0.00%
0/25 • Up to 12 weeks plus 30 days.
Adverse events are included up to the last dose date of any study drug + 30 days.
|
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