Trial Outcomes & Findings for A Study to Learn About the Effects and Safety of RTA 408 (Omaveloxolone) in People Aged 16 to 40 With Friedreich's Ataxia (NCT NCT02255435)
NCT ID: NCT02255435
Last Updated: 2025-12-31
Results Overview
Peak work attained during maximal exercise testing. Cycle ergometry using a recumbent stationary bicycle was used, and workload was increased incrementally. Peak work is defined as the workload at which patients reach maximal volition (defined as an inability to continue to exercise due to exhaustion).
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
172 participants
Primary outcome timeframe
Baseline through 12 weeks after participant receives the first dose in Part 1.
Results posted on
2025-12-31
Participant Flow
MOXIe Part 1 and Part 2 were conducted under the same protocol. Participants enrolled in Part 1 were not allowed to enroll in Part 2. Patients with pes cavus were not to comprise more than 20% of all patients enrolled in Part 2.
Participant milestones
| Measure |
Part 1 Omaveloxolone Capsules 2.5 and 5 mg
Omaveloxolone (RTA 408) Capsules, 2.5 mg administered orally one daily for 2 weeks, then 5 mg administered orally once daily for 10 weeks
Omaveloxolone Capsules, 2.5 mg
Omaveloxolone Capsules, 5 mg
|
Part 1 Omaveloxolone Capsules 10 mg
Omaveloxolone (RTA 408) Capsules, 10 mg administered orally once daily for 12 weeks
Omaveloxolone Capsules, 10 mg
|
Part 1 Omaveloxolone Capsules 20 mg
Omaveloxolone (RTA 408) Capsules, 20 mg administered orally once daily for 12 weeks
Omaveloxolone Capsules, 20 mg
|
Part 1 Omaveloxolone Capsules 40 mg
Omaveloxolone (RTA 408) Capsules, 40 mg administered orally once daily for 12 weeks
Omaveloxolone Capsules, 40 mg
|
Part 1 Omaveloxolone Capsules 80 mg
Omaveloxolone (RTA 408) Capsules, 80 mg administered orally once daily for 12 weeks
Omaveloxolone Capsules, 80 mg
|
Part 1 Omaveloxolone Capsules 160 mg
Omaveloxolone (RTA 408) Capsules, 160 mg administered orally once daily for 12 weeks
Omaveloxolone Capsules, 160 mg
|
Part 1 Omaveloxolone Capsules 300 mg
Omaveloxolone (RTA 408) Capsules, 300 mg administered orally once daily for 12 weeks
Omaveloxolone Capsules, 300 mg
|
Part 1 Placebo Capsules
Placebo capsules administered orally once daily for 12 weeks
Placebo
|
Part 2 Placebo Capsules
Placebo capsules administered orally once daily for 48 weeks
Placebo
|
Part 2 Omaveloxolone Capsules 150 mg
Omaveloxolone (RTA 408) Capsules, 150 mg administered orally once daily for 48 weeks
Omaveloxolone Capsules, 150 mg
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
6
|
6
|
6
|
12
|
10
|
17
|
52
|
51
|
|
Overall Study
Number of Participants With Pes Cavus
|
2
|
2
|
3
|
2
|
2
|
8
|
3
|
10
|
10
|
10
|
|
Overall Study
COMPLETED
|
6
|
6
|
6
|
6
|
6
|
12
|
10
|
16
|
51
|
45
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
6
|
Reasons for withdrawal
| Measure |
Part 1 Omaveloxolone Capsules 2.5 and 5 mg
Omaveloxolone (RTA 408) Capsules, 2.5 mg administered orally one daily for 2 weeks, then 5 mg administered orally once daily for 10 weeks
Omaveloxolone Capsules, 2.5 mg
Omaveloxolone Capsules, 5 mg
|
Part 1 Omaveloxolone Capsules 10 mg
Omaveloxolone (RTA 408) Capsules, 10 mg administered orally once daily for 12 weeks
Omaveloxolone Capsules, 10 mg
|
Part 1 Omaveloxolone Capsules 20 mg
Omaveloxolone (RTA 408) Capsules, 20 mg administered orally once daily for 12 weeks
Omaveloxolone Capsules, 20 mg
|
Part 1 Omaveloxolone Capsules 40 mg
Omaveloxolone (RTA 408) Capsules, 40 mg administered orally once daily for 12 weeks
Omaveloxolone Capsules, 40 mg
|
Part 1 Omaveloxolone Capsules 80 mg
Omaveloxolone (RTA 408) Capsules, 80 mg administered orally once daily for 12 weeks
Omaveloxolone Capsules, 80 mg
|
Part 1 Omaveloxolone Capsules 160 mg
Omaveloxolone (RTA 408) Capsules, 160 mg administered orally once daily for 12 weeks
Omaveloxolone Capsules, 160 mg
|
Part 1 Omaveloxolone Capsules 300 mg
Omaveloxolone (RTA 408) Capsules, 300 mg administered orally once daily for 12 weeks
Omaveloxolone Capsules, 300 mg
|
Part 1 Placebo Capsules
Placebo capsules administered orally once daily for 12 weeks
Placebo
|
Part 2 Placebo Capsules
Placebo capsules administered orally once daily for 48 weeks
Placebo
|
Part 2 Omaveloxolone Capsules 150 mg
Omaveloxolone (RTA 408) Capsules, 150 mg administered orally once daily for 48 weeks
Omaveloxolone Capsules, 150 mg
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Patient's Limited Time Availability
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
4
|
|
Overall Study
Administrative reasons
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
Baseline Characteristics
A Study to Learn About the Effects and Safety of RTA 408 (Omaveloxolone) in People Aged 16 to 40 With Friedreich's Ataxia
Baseline characteristics by cohort
| Measure |
Part 1 Omaveloxolone Capsules 2.5 and 5 mg
n=6 Participants
Omaveloxolone (RTA 408) Capsules, 2.5 mg administered orally one daily for 2 weeks, then 5 mg administered orally once daily for 10 weeks
Omaveloxolone Capsules, 2.5 mg
Omaveloxolone Capsules, 5 mg
|
Part 1 Omaveloxolone Capsules 10 mg
n=6 Participants
Omaveloxolone (RTA 408) Capsules, 10 mg administered orally once daily for 12 weeks
Omaveloxolone Capsules, 10 mg
|
Part 1 Omaveloxolone Capsules 20 mg
n=6 Participants
Omaveloxolone (RTA 408) Capsules, 20 mg administered orally once daily for 12 weeks
Omaveloxolone Capsules, 20 mg
|
Part 1 Omaveloxolone Capsules 40 mg
n=6 Participants
Omaveloxolone (RTA 408) Capsules, 40 mg administered orally once daily for 12 weeks
Omaveloxolone Capsules, 40 mg
|
Part 1 Omaveloxolone Capsules 80 mg
n=6 Participants
Omaveloxolone (RTA 408) Capsules, 80 mg administered orally once daily for 12 weeks
Omaveloxolone Capsules, 80 mg
|
Part 1 Omaveloxolone Capsules 160 mg
n=12 Participants
Omaveloxolone (RTA 408) Capsules, 160 mg administered orally once daily for 12 weeks
Omaveloxolone Capsules, 160 mg
|
Part 1 Omaveloxolone Capsules 300 mg
n=10 Participants
Omaveloxolone (RTA 408) Capsules, 300 mg administered orally once daily for 12 weeks
Omaveloxolone Capsules, 300 mg
|
Part 1 Placebo Capsules
n=17 Participants
Placebo capsules administered orally once daily for 12 weeks
Placebo
|
Part 2 Placebo Capsules
n=52 Participants
Placebo capsules administered orally once daily for 48 weeks
Placebo
|
Part 2 Omaveloxolone Capsules 150 mg
n=51 Participants
Omaveloxolone (RTA 408) Capsules, 150 mg administered orally once daily for 48 weeks
Omaveloxolone Capsules, 150 mg
|
Total
n=172 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
25.8 years
STANDARD_DEVIATION 5.98 • n=1000 Participants
|
25.5 years
STANDARD_DEVIATION 7.4 • n=1986 Participants
|
28.3 years
STANDARD_DEVIATION 6.8 • n=2008 Participants
|
27.7 years
STANDARD_DEVIATION 7.53 • n=4994 Participants
|
24.3 years
STANDARD_DEVIATION 4.8 • n=62 Participants
|
25.3 years
STANDARD_DEVIATION 6.51 • n=357 Participants
|
25.6 years
STANDARD_DEVIATION 7.24 • n=6 Participants
|
24.4 years
STANDARD_DEVIATION 6.74 • n=6 Participants
|
24.1 years
STANDARD_DEVIATION 7.85 • n=47 Participants
|
23.4 years
STANDARD_DEVIATION 6.08 • n=18 Participants
|
24.5 years
STANDARD_DEVIATION 6.84 • n=18 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=1000 Participants
|
4 Participants
n=1986 Participants
|
5 Participants
n=2008 Participants
|
1 Participants
n=4994 Participants
|
3 Participants
n=62 Participants
|
5 Participants
n=357 Participants
|
5 Participants
n=6 Participants
|
10 Participants
n=6 Participants
|
17 Participants
n=47 Participants
|
31 Participants
n=18 Participants
|
85 Participants
n=18 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=1000 Participants
|
2 Participants
n=1986 Participants
|
1 Participants
n=2008 Participants
|
5 Participants
n=4994 Participants
|
3 Participants
n=62 Participants
|
7 Participants
n=357 Participants
|
5 Participants
n=6 Participants
|
7 Participants
n=6 Participants
|
35 Participants
n=47 Participants
|
20 Participants
n=18 Participants
|
87 Participants
n=18 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=1000 Participants
|
1 Participants
n=1986 Participants
|
0 Participants
n=2008 Participants
|
0 Participants
n=4994 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=357 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
3 Participants
n=47 Participants
|
2 Participants
n=18 Participants
|
7 Participants
n=18 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=1000 Participants
|
5 Participants
n=1986 Participants
|
6 Participants
n=2008 Participants
|
6 Participants
n=4994 Participants
|
6 Participants
n=62 Participants
|
12 Participants
n=357 Participants
|
10 Participants
n=6 Participants
|
16 Participants
n=6 Participants
|
49 Participants
n=47 Participants
|
49 Participants
n=18 Participants
|
165 Participants
n=18 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=1000 Participants
|
0 Participants
n=1986 Participants
|
0 Participants
n=2008 Participants
|
0 Participants
n=4994 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=357 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=47 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=18 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=1000 Participants
|
0 Participants
n=1986 Participants
|
0 Participants
n=2008 Participants
|
0 Participants
n=4994 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=357 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=47 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=1000 Participants
|
0 Participants
n=1986 Participants
|
0 Participants
n=2008 Participants
|
0 Participants
n=4994 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=357 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=47 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=1000 Participants
|
0 Participants
n=1986 Participants
|
0 Participants
n=2008 Participants
|
0 Participants
n=4994 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=357 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=47 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=1000 Participants
|
0 Participants
n=1986 Participants
|
0 Participants
n=2008 Participants
|
0 Participants
n=4994 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=357 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=47 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=18 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=1000 Participants
|
6 Participants
n=1986 Participants
|
6 Participants
n=2008 Participants
|
6 Participants
n=4994 Participants
|
6 Participants
n=62 Participants
|
11 Participants
n=357 Participants
|
10 Participants
n=6 Participants
|
16 Participants
n=6 Participants
|
50 Participants
n=47 Participants
|
50 Participants
n=18 Participants
|
167 Participants
n=18 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=1000 Participants
|
0 Participants
n=1986 Participants
|
0 Participants
n=2008 Participants
|
0 Participants
n=4994 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=357 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=47 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=1000 Participants
|
0 Participants
n=1986 Participants
|
0 Participants
n=2008 Participants
|
0 Participants
n=4994 Participants
|
0 Participants
n=62 Participants
|
1 Participants
n=357 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
2 Participants
n=47 Participants
|
1 Participants
n=18 Participants
|
5 Participants
n=18 Participants
|
|
Region of Enrollment
Austria
|
0 participants
n=1000 Participants
|
0 participants
n=1986 Participants
|
0 participants
n=2008 Participants
|
0 participants
n=4994 Participants
|
0 participants
n=62 Participants
|
3 participants
n=357 Participants
|
2 participants
n=6 Participants
|
0 participants
n=6 Participants
|
6 participants
n=47 Participants
|
3 participants
n=18 Participants
|
14 participants
n=18 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=1000 Participants
|
6 participants
n=1986 Participants
|
6 participants
n=2008 Participants
|
6 participants
n=4994 Participants
|
5 participants
n=62 Participants
|
8 participants
n=357 Participants
|
7 participants
n=6 Participants
|
16 participants
n=6 Participants
|
35 participants
n=47 Participants
|
36 participants
n=18 Participants
|
131 participants
n=18 Participants
|
|
Region of Enrollment
United Kingdom
|
0 participants
n=1000 Participants
|
0 participants
n=1986 Participants
|
0 participants
n=2008 Participants
|
0 participants
n=4994 Participants
|
0 participants
n=62 Participants
|
0 participants
n=357 Participants
|
0 participants
n=6 Participants
|
0 participants
n=6 Participants
|
3 participants
n=47 Participants
|
5 participants
n=18 Participants
|
8 participants
n=18 Participants
|
|
Region of Enrollment
Italy
|
0 participants
n=1000 Participants
|
0 participants
n=1986 Participants
|
0 participants
n=2008 Participants
|
0 participants
n=4994 Participants
|
0 participants
n=62 Participants
|
0 participants
n=357 Participants
|
0 participants
n=6 Participants
|
0 participants
n=6 Participants
|
5 participants
n=47 Participants
|
2 participants
n=18 Participants
|
7 participants
n=18 Participants
|
|
Region of Enrollment
Australia
|
0 participants
n=1000 Participants
|
0 participants
n=1986 Participants
|
0 participants
n=2008 Participants
|
0 participants
n=4994 Participants
|
1 participants
n=62 Participants
|
1 participants
n=357 Participants
|
1 participants
n=6 Participants
|
1 participants
n=6 Participants
|
3 participants
n=47 Participants
|
5 participants
n=18 Participants
|
12 participants
n=18 Participants
|
|
Peak Work
|
1.2 W/kg
STANDARD_DEVIATION 0.696 • n=1000 Participants
|
0.78 W/kg
STANDARD_DEVIATION 0.677 • n=1986 Participants
|
1.25 W/kg
STANDARD_DEVIATION 0.838 • n=2008 Participants
|
0.72 W/kg
STANDARD_DEVIATION 0.565 • n=4994 Participants
|
1.6 W/kg
STANDARD_DEVIATION 0.556 • n=62 Participants
|
1.18 W/kg
STANDARD_DEVIATION 0.646 • n=357 Participants
|
0.88 W/kg
STANDARD_DEVIATION 0.521 • n=6 Participants
|
0.99 W/kg
STANDARD_DEVIATION 0.637 • n=6 Participants
|
1.23 W/kg
STANDARD_DEVIATION 0.622 • n=47 Participants
|
1.09 W/kg
STANDARD_DEVIATION 0.576 • n=18 Participants
|
1.12 W/kg
STANDARD_DEVIATION 0.621 • n=18 Participants
|
PRIMARY outcome
Timeframe: Baseline through 12 weeks after participant receives the first dose in Part 1.Population: All randomized patients in Part 1, whether or not they received study drug
Peak work attained during maximal exercise testing. Cycle ergometry using a recumbent stationary bicycle was used, and workload was increased incrementally. Peak work is defined as the workload at which patients reach maximal volition (defined as an inability to continue to exercise due to exhaustion).
Outcome measures
| Measure |
Part 1 Omaveloxolone Capsules 2.5 and 5 mg
n=6 Participants
Omaveloxolone (RTA 408) Capsules, 2.5 mg administered orally one daily for 2 weeks, then 5 mg administered orally once daily for 10 weeks
Omaveloxolone Capsules, 2.5 mg
Omaveloxolone Capsules, 5 mg
|
Part 1 Omaveloxolone Capsules 10 mg
n=6 Participants
Omaveloxolone (RTA 408) Capsules, 10 mg administered orally once daily for 12 weeks
Omaveloxolone Capsules, 10 mg
|
Part 1 Omaveloxolone Capsules 20 mg
n=6 Participants
Omaveloxolone (RTA 408) Capsules, 20 mg administered orally once daily for 12 weeks
Omaveloxolone Capsules, 20 mg
|
Part 1 Omaveloxolone Capsules 40 mg
n=6 Participants
Omaveloxolone (RTA 408) Capsules, 40 mg administered orally once daily for 12 weeks
Omaveloxolone Capsules, 40 mg
|
Part 1 Omaveloxolone Capsules 80 mg
n=6 Participants
Omaveloxolone (RTA 408) Capsules, 80 mg administered orally once daily for 12 weeks
Omaveloxolone Capsules, 80 mg
|
Part 1 Omaveloxolone Capsules 160 mg
n=12 Participants
Omaveloxolone (RTA 408) Capsules, 160 mg administered orally once daily for 12 weeks
Omaveloxolone Capsules, 160 mg
|
Part 1 Omaveloxolone Capsules 300 mg
n=10 Participants
Omaveloxolone (RTA 408) Capsules, 300 mg administered orally once daily for 12 weeks
Omaveloxolone Capsules, 300 mg
|
Part 1 Placebo Capsules
n=17 Participants
Placebo capsules administered orally once daily for 12 weeks
Placebo
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Peak Work (in Watts/kg) During Exercise Testing at Week 12 in Part 1
|
0.14 W/kg
Interval 0.02 to 0.26
|
0.07 W/kg
Interval -0.05 to 0.18
|
-0.09 W/kg
Interval -0.2 to 0.03
|
0.06 W/kg
Interval -0.06 to 0.18
|
0 W/kg
Interval -0.11 to 0.12
|
0.02 W/kg
Interval -0.06 to 0.1
|
0.07 W/kg
Interval -0.02 to 0.17
|
0.04 W/kg
Interval -0.03 to 0.11
|
PRIMARY outcome
Timeframe: 48 weeks after participant receives the first dose in Part 2Population: Full analysis set (all patients in Part 2 randomized without pes cavus who have at least one post-baseline measurement)
The mFARS includes 4 of the 5 sections of the Friedreich's Ataxia Rating Scale (FARS): bulbar (score 0 to 11), upper limb coordination (score 0 to 36), lower limb coordination (score 0 to 16), and upright stability (score 0 to 36). The minimum score is 0 and the maximum score is 99. A lower score indicates better neurological function.
Outcome measures
| Measure |
Part 1 Omaveloxolone Capsules 2.5 and 5 mg
n=42 Participants
Omaveloxolone (RTA 408) Capsules, 2.5 mg administered orally one daily for 2 weeks, then 5 mg administered orally once daily for 10 weeks
Omaveloxolone Capsules, 2.5 mg
Omaveloxolone Capsules, 5 mg
|
Part 1 Omaveloxolone Capsules 10 mg
n=40 Participants
Omaveloxolone (RTA 408) Capsules, 10 mg administered orally once daily for 12 weeks
Omaveloxolone Capsules, 10 mg
|
Part 1 Omaveloxolone Capsules 20 mg
Omaveloxolone (RTA 408) Capsules, 20 mg administered orally once daily for 12 weeks
Omaveloxolone Capsules, 20 mg
|
Part 1 Omaveloxolone Capsules 40 mg
Omaveloxolone (RTA 408) Capsules, 40 mg administered orally once daily for 12 weeks
Omaveloxolone Capsules, 40 mg
|
Part 1 Omaveloxolone Capsules 80 mg
Omaveloxolone (RTA 408) Capsules, 80 mg administered orally once daily for 12 weeks
Omaveloxolone Capsules, 80 mg
|
Part 1 Omaveloxolone Capsules 160 mg
Omaveloxolone (RTA 408) Capsules, 160 mg administered orally once daily for 12 weeks
Omaveloxolone Capsules, 160 mg
|
Part 1 Omaveloxolone Capsules 300 mg
Omaveloxolone (RTA 408) Capsules, 300 mg administered orally once daily for 12 weeks
Omaveloxolone Capsules, 300 mg
|
Part 1 Placebo Capsules
Placebo capsules administered orally once daily for 12 weeks
Placebo
|
|---|---|---|---|---|---|---|---|---|
|
Change in the Modified Friedreich's Ataxia Rating Scale (mFARS) at Week 48 in Part 2
|
0.85 score on a scale
Standard Error 0.640
|
-1.55 score on a scale
Standard Error 0.689
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 12 weeks after participant receives the first dose in Part 1Population: All randomized patients in Part 1, whether or not they received study drug
The mFARS includes 4 of the 5 sections of the Friedreich's Ataxia Rating Scale (FARS): bulbar (score 0 to 11), upper limb coordination (score 0 to 36), lower limb coordination (score 0 to 16), and upright stability (score 0 to 36). The minimum score is 0 and the maximum score is 99. A lower score indicates better neurological function.
Outcome measures
| Measure |
Part 1 Omaveloxolone Capsules 2.5 and 5 mg
n=6 Participants
Omaveloxolone (RTA 408) Capsules, 2.5 mg administered orally one daily for 2 weeks, then 5 mg administered orally once daily for 10 weeks
Omaveloxolone Capsules, 2.5 mg
Omaveloxolone Capsules, 5 mg
|
Part 1 Omaveloxolone Capsules 10 mg
n=6 Participants
Omaveloxolone (RTA 408) Capsules, 10 mg administered orally once daily for 12 weeks
Omaveloxolone Capsules, 10 mg
|
Part 1 Omaveloxolone Capsules 20 mg
n=6 Participants
Omaveloxolone (RTA 408) Capsules, 20 mg administered orally once daily for 12 weeks
Omaveloxolone Capsules, 20 mg
|
Part 1 Omaveloxolone Capsules 40 mg
n=6 Participants
Omaveloxolone (RTA 408) Capsules, 40 mg administered orally once daily for 12 weeks
Omaveloxolone Capsules, 40 mg
|
Part 1 Omaveloxolone Capsules 80 mg
n=6 Participants
Omaveloxolone (RTA 408) Capsules, 80 mg administered orally once daily for 12 weeks
Omaveloxolone Capsules, 80 mg
|
Part 1 Omaveloxolone Capsules 160 mg
n=12 Participants
Omaveloxolone (RTA 408) Capsules, 160 mg administered orally once daily for 12 weeks
Omaveloxolone Capsules, 160 mg
|
Part 1 Omaveloxolone Capsules 300 mg
n=10 Participants
Omaveloxolone (RTA 408) Capsules, 300 mg administered orally once daily for 12 weeks
Omaveloxolone Capsules, 300 mg
|
Part 1 Placebo Capsules
n=17 Participants
Placebo capsules administered orally once daily for 12 weeks
Placebo
|
|---|---|---|---|---|---|---|---|---|
|
Change in the Modified Friedreich's Ataxia Rating Scale (mFARS) at Week 12 in Part 1
|
-3.26 score on a scale
Interval -5.82 to -0.7
|
-1.97 score on a scale
Interval -4.53 to 0.59
|
-2.44 score on a scale
Interval -5.0 to 0.12
|
-2.4 score on a scale
Interval -4.96 to 0.16
|
-2.88 score on a scale
Interval -5.44 to -0.31
|
-3.75 score on a scale
Interval -5.56 to -1.94
|
-0.88 score on a scale
Interval -2.86 to 1.11
|
-1.43 score on a scale
Interval -2.97 to 0.11
|
Adverse Events
Part 1 Omaveloxolone Capsules 160 mg
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Part 1 Omaveloxolone Capsules 300 mg
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Part 1 Placebo Capsules
Serious events: 2 serious events
Other events: 16 other events
Deaths: 0 deaths
Part 2 Placebo Capsules
Serious events: 3 serious events
Other events: 52 other events
Deaths: 0 deaths
Part 2 Omaveloxolone Capsules 150 mg
Serious events: 5 serious events
Other events: 51 other events
Deaths: 0 deaths
Part 1 Omaveloxolone Capsules 80 mg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Part 1 Omaveloxolone Capsules 2.5 and 5 mg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Part 1 Omaveloxolone Capsules 10 mg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Part 1 Omaveloxolone Capsules 20 mg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Part 1 Omaveloxolone Capsules 40 mg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Part 1 Omaveloxolone Capsules 160 mg
n=12 participants at risk
Omaveloxolone (RTA 408) Capsules, 160 mg administered orally once daily for 12 weeks
Omaveloxolone Capsules, 160 mg
|
Part 1 Omaveloxolone Capsules 300 mg
n=10 participants at risk
Omaveloxolone (RTA 408) Capsules, 300 mg administered orally once daily for 12 weeks
Omaveloxolone Capsules, 300 mg
|
Part 1 Placebo Capsules
n=17 participants at risk
Placebo capsules administered orally once daily for 12 weeks
Placebo
|
Part 2 Placebo Capsules
n=52 participants at risk
Placebo capsules administered orally once daily for 48 weeks
Placebo
|
Part 2 Omaveloxolone Capsules 150 mg
n=51 participants at risk
Omaveloxolone (RTA 408) Capsules, 150 mg administered orally once daily for 48 weeks
Omaveloxolone Capsules, 150 mg
|
Part 1 Omaveloxolone Capsules 80 mg
n=6 participants at risk
Omaveloxolone (RTA 408) Capsules, 80 mg administered orally once daily for 12 weeks
Omaveloxolone Capsules, 80 mg
|
Part 1 Omaveloxolone Capsules 2.5 and 5 mg
n=6 participants at risk
Omaveloxolone (RTA 408) Capsules, 2.5 mg administered orally one daily for 2 weeks, then 5 mg administered orally once daily for 10 weeks
Omaveloxolone Capsules, 2.5 mg
Omaveloxolone Capsules, 5 mg
|
Part 1 Omaveloxolone Capsules 10 mg
n=6 participants at risk
Omaveloxolone (RTA 408) Capsules, 10 mg administered orally once daily for 12 weeks
Omaveloxolone Capsules, 10 mg
|
Part 1 Omaveloxolone Capsules 20 mg
n=6 participants at risk
Omaveloxolone (RTA 408) Capsules, 20 mg administered orally once daily for 12 weeks
Omaveloxolone Capsules, 20 mg
|
Part 1 Omaveloxolone Capsules 40 mg
n=6 participants at risk
Omaveloxolone (RTA 408) Capsules, 40 mg administered orally once daily for 12 weeks
Omaveloxolone Capsules, 40 mg
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/12 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/10 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/17 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/52 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
2.0%
1/51 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/12 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/10 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/17 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
1.9%
1/52 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
2.0%
1/51 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/12 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/10 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/17 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/52 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
2.0%
1/51 • Number of events 2 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/12 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/10 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/17 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/52 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
2.0%
1/51 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/12 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/10 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/17 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/52 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
2.0%
1/51 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
|
General disorders
Drug withdrawal syndrome
|
0.00%
0/12 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/10 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
5.9%
1/17 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/52 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/51 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/12 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/10 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/17 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/52 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
2.0%
1/51 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
|
Hepatobiliary disorders
Gallbladder disorder
|
0.00%
0/12 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/10 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/17 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
1.9%
1/52 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/51 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
|
Infections and infestations
Laryngitis
|
0.00%
0/12 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/10 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/17 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/52 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
2.0%
1/51 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/12 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/10 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/17 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/52 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
2.0%
1/51 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/12 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/10 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/17 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
1.9%
1/52 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/51 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
|
Injury, poisoning and procedural complications
Burns third degree
|
0.00%
0/12 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/10 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
5.9%
1/17 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/52 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/51 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.00%
0/12 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/10 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/17 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/52 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
2.0%
1/51 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
Other adverse events
| Measure |
Part 1 Omaveloxolone Capsules 160 mg
n=12 participants at risk
Omaveloxolone (RTA 408) Capsules, 160 mg administered orally once daily for 12 weeks
Omaveloxolone Capsules, 160 mg
|
Part 1 Omaveloxolone Capsules 300 mg
n=10 participants at risk
Omaveloxolone (RTA 408) Capsules, 300 mg administered orally once daily for 12 weeks
Omaveloxolone Capsules, 300 mg
|
Part 1 Placebo Capsules
n=17 participants at risk
Placebo capsules administered orally once daily for 12 weeks
Placebo
|
Part 2 Placebo Capsules
n=52 participants at risk
Placebo capsules administered orally once daily for 48 weeks
Placebo
|
Part 2 Omaveloxolone Capsules 150 mg
n=51 participants at risk
Omaveloxolone (RTA 408) Capsules, 150 mg administered orally once daily for 48 weeks
Omaveloxolone Capsules, 150 mg
|
Part 1 Omaveloxolone Capsules 80 mg
n=6 participants at risk
Omaveloxolone (RTA 408) Capsules, 80 mg administered orally once daily for 12 weeks
Omaveloxolone Capsules, 80 mg
|
Part 1 Omaveloxolone Capsules 2.5 and 5 mg
n=6 participants at risk
Omaveloxolone (RTA 408) Capsules, 2.5 mg administered orally one daily for 2 weeks, then 5 mg administered orally once daily for 10 weeks
Omaveloxolone Capsules, 2.5 mg
Omaveloxolone Capsules, 5 mg
|
Part 1 Omaveloxolone Capsules 10 mg
n=6 participants at risk
Omaveloxolone (RTA 408) Capsules, 10 mg administered orally once daily for 12 weeks
Omaveloxolone Capsules, 10 mg
|
Part 1 Omaveloxolone Capsules 20 mg
n=6 participants at risk
Omaveloxolone (RTA 408) Capsules, 20 mg administered orally once daily for 12 weeks
Omaveloxolone Capsules, 20 mg
|
Part 1 Omaveloxolone Capsules 40 mg
n=6 participants at risk
Omaveloxolone (RTA 408) Capsules, 40 mg administered orally once daily for 12 weeks
Omaveloxolone Capsules, 40 mg
|
|---|---|---|---|---|---|---|---|---|---|---|
|
General disorders
Pain
|
0.00%
0/12 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/10 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/17 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/52 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/51 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
16.7%
1/6 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/12 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/10 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
5.9%
1/17 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/52 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
2.0%
1/51 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
|
Cardiac disorders
Palpitations
|
8.3%
1/12 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/10 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/17 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
3.8%
2/52 • Number of events 2 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
2.0%
1/51 • Number of events 4 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
|
Cardiac disorders
Tachycardia
|
8.3%
1/12 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/10 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/17 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
1.9%
1/52 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/51 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
16.7%
1/6 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/12 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/10 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/17 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
3.8%
2/52 • Number of events 2 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/51 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
|
Congenital, familial and genetic disorders
Friedreich's ataxia
|
0.00%
0/12 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/10 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
5.9%
1/17 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/52 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/51 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/12 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/10 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/17 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/52 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
3.9%
2/51 • Number of events 2 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
|
Eye disorders
Ocular hyperaemia
|
8.3%
1/12 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/10 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
5.9%
1/17 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/52 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/51 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/12 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/10 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/17 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/52 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
5.9%
3/51 • Number of events 3 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/12 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/10 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
5.9%
1/17 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/52 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
3.9%
2/51 • Number of events 2 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
|
Gastrointestinal disorders
Abdominal pain
|
8.3%
1/12 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/10 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
5.9%
1/17 • Number of events 2 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
5.8%
3/52 • Number of events 3 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
21.6%
11/51 • Number of events 21 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
16.7%
1/6 • Number of events 2 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
16.7%
1/6 • Number of events 2 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
8.3%
1/12 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/10 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
17.6%
3/17 • Number of events 3 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/52 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/51 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
|
Gastrointestinal disorders
Abnormal faeces
|
0.00%
0/12 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
10.0%
1/10 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/17 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/52 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/51 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/12 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/10 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
11.8%
2/17 • Number of events 2 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/52 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
3.9%
2/51 • Number of events 2 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
16.7%
1/6 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
16.7%
1/6 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
|
Gastrointestinal disorders
Diarrhoea
|
25.0%
3/12 • Number of events 3 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
10.0%
1/10 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
5.9%
1/17 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
9.6%
5/52 • Number of events 6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
19.6%
10/51 • Number of events 12 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
16.7%
1/6 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
16.7%
1/6 • Number of events 2 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
|
Gastrointestinal disorders
Dry mouth
|
8.3%
1/12 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/10 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/17 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/52 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/51 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
16.7%
1/6 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/12 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/10 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
5.9%
1/17 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
1.9%
1/52 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
3.9%
2/51 • Number of events 2 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/12 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/10 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/17 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
3.8%
2/52 • Number of events 2 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/51 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/12 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/10 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/17 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/52 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
3.9%
2/51 • Number of events 2 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
16.7%
1/6 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/12 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/10 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
5.9%
1/17 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/52 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/51 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/12 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
10.0%
1/10 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/17 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/52 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
2.0%
1/51 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
|
Gastrointestinal disorders
Nausea
|
8.3%
1/12 • Number of events 2 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
20.0%
2/10 • Number of events 3 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
5.9%
1/17 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
13.5%
7/52 • Number of events 8 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
33.3%
17/51 • Number of events 22 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
16.7%
1/6 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
16.7%
1/6 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/12 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
10.0%
1/10 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/17 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
11.5%
6/52 • Number of events 6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
15.7%
8/51 • Number of events 9 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
16.7%
1/6 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
|
General disorders
Chills
|
8.3%
1/12 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/10 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/17 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
1.9%
1/52 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
2.0%
1/51 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
|
General disorders
Energy increased
|
8.3%
1/12 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/10 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/17 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/52 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/51 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
|
General disorders
Fatigue
|
8.3%
1/12 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/10 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
11.8%
2/17 • Number of events 2 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
13.5%
7/52 • Number of events 7 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
21.6%
11/51 • Number of events 11 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
33.3%
2/6 • Number of events 2 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
50.0%
3/6 • Number of events 3 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
|
General disorders
Gait disturbance
|
0.00%
0/12 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/10 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/17 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
5.8%
3/52 • Number of events 3 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
3.9%
2/51 • Number of events 2 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
|
General disorders
Influenza like illness
|
0.00%
0/12 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/10 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
5.9%
1/17 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
1.9%
1/52 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
5.9%
3/51 • Number of events 3 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
33.3%
2/6 • Number of events 2 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/12 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/10 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/17 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
3.8%
2/52 • Number of events 2 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
2.0%
1/51 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
|
General disorders
Pyrexia
|
0.00%
0/12 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/10 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/17 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
7.7%
4/52 • Number of events 6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
3.9%
2/51 • Number of events 2 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/12 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/10 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/17 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
3.8%
2/52 • Number of events 11 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/51 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
|
Infections and infestations
Abscess
|
0.00%
0/12 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
10.0%
1/10 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/17 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/52 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/51 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
|
Infections and infestations
Gastroenteritis
|
8.3%
1/12 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/10 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/17 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/52 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/51 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
16.7%
1/6 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/12 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/10 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/17 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/52 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/51 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
16.7%
1/6 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
|
Infections and infestations
Gastrointestinal infection
|
0.00%
0/12 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/10 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/17 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
3.8%
2/52 • Number of events 2 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
5.9%
3/51 • Number of events 4 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
|
Infections and infestations
Gastrointestinal viral infection
|
0.00%
0/12 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/10 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/17 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/52 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/51 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
16.7%
1/6 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
|
Infections and infestations
Influenza
|
0.00%
0/12 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/10 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/17 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
3.8%
2/52 • Number of events 2 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
9.8%
5/51 • Number of events 8 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
|
Infections and infestations
Nasopharyngitis
|
25.0%
3/12 • Number of events 3 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
30.0%
3/10 • Number of events 3 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/17 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
17.3%
9/52 • Number of events 13 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
13.7%
7/51 • Number of events 7 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
16.7%
1/6 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
16.7%
1/6 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/12 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/10 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/17 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
3.8%
2/52 • Number of events 2 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
2.0%
1/51 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/12 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/10 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
5.9%
1/17 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/52 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/51 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
|
Infections and infestations
Respiratory tract infection viral
|
0.00%
0/12 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/10 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/17 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
3.8%
2/52 • Number of events 3 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/51 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/12 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
10.0%
1/10 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/17 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
3.8%
2/52 • Number of events 2 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/51 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/12 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/10 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/17 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
3.8%
2/52 • Number of events 2 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
2.0%
1/51 • Number of events 2 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
16.7%
1/6 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
|
Infections and infestations
Upper respiratory tract infection
|
33.3%
4/12 • Number of events 4 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
60.0%
6/10 • Number of events 10 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
5.9%
1/17 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
28.8%
15/52 • Number of events 29 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
27.5%
14/51 • Number of events 20 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
33.3%
2/6 • Number of events 3 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
33.3%
2/6 • Number of events 4 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
16.7%
1/6 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
83.3%
5/6 • Number of events 5 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
33.3%
2/6 • Number of events 2 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/12 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/10 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/17 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/52 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
7.8%
4/51 • Number of events 5 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
16.7%
1/6 • Number of events 2 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
|
Infections and infestations
Viral infection
|
8.3%
1/12 • Number of events 2 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/10 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/17 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
5.8%
3/52 • Number of events 3 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/51 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/12 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/10 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
5.9%
1/17 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
1.9%
1/52 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
2.0%
1/51 • Number of events 2 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
|
Injury, poisoning and procedural complications
Burns second degree
|
0.00%
0/12 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/10 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/17 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
3.8%
2/52 • Number of events 3 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/51 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
|
Injury, poisoning and procedural complications
Burns third degree
|
0.00%
0/12 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/10 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
5.9%
1/17 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/52 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/51 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/12 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/10 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/17 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
1.9%
1/52 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
3.9%
2/51 • Number of events 2 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
|
Injury, poisoning and procedural complications
Contusion
|
8.3%
1/12 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
10.0%
1/10 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/17 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
36.5%
19/52 • Number of events 43 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
33.3%
17/51 • Number of events 29 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/12 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/10 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
5.9%
1/17 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
23.1%
12/52 • Number of events 21 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
25.5%
13/51 • Number of events 18 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
16.7%
1/6 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
16.7%
1/6 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
|
Injury, poisoning and procedural complications
Face injury
|
8.3%
1/12 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/10 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/17 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/52 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/51 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/12 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/10 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
5.9%
1/17 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/52 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/51 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
16.7%
1/6 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/12 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/10 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/17 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
1.9%
1/52 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
3.9%
2/51 • Number of events 2 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
16.7%
1/6 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/12 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
10.0%
1/10 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
5.9%
1/17 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
3.8%
2/52 • Number of events 2 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
2.0%
1/51 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/12 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/10 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
5.9%
1/17 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
1.9%
1/52 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/51 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/12 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/10 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/17 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
5.8%
3/52 • Number of events 3 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
7.8%
4/51 • Number of events 4 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
|
Injury, poisoning and procedural complications
Laceration
|
8.3%
1/12 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/10 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/17 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
15.4%
8/52 • Number of events 10 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
15.7%
8/51 • Number of events 16 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
8.3%
1/12 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/10 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
17.6%
3/17 • Number of events 3 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
15.4%
8/52 • Number of events 12 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
9.8%
5/51 • Number of events 7 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/12 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/10 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/17 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
1.9%
1/52 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
9.8%
5/51 • Number of events 5 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
8.3%
1/12 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/10 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/17 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
3.8%
2/52 • Number of events 3 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
5.9%
3/51 • Number of events 3 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
|
Injury, poisoning and procedural complications
Periorbital haematoma
|
8.3%
1/12 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/10 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/17 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
1.9%
1/52 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/51 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/12 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/10 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/17 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
1.9%
1/52 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/51 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
16.7%
1/6 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
|
Injury, poisoning and procedural complications
Sunburn
|
8.3%
1/12 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/10 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/17 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/52 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/51 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/12 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/10 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
5.9%
1/17 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
1.9%
1/52 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/51 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
16.7%
1/6 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
16.7%
1/6 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
|
Investigations
Alanine aminotransferase increased
|
16.7%
2/12 • Number of events 2 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
20.0%
2/10 • Number of events 2 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/17 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
1.9%
1/52 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
37.3%
19/51 • Number of events 20 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
16.7%
1/6 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
16.7%
1/6 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
|
Investigations
Aspartate aminotransferase increased
|
16.7%
2/12 • Number of events 2 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
20.0%
2/10 • Number of events 2 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/17 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
1.9%
1/52 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
21.6%
11/51 • Number of events 12 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
16.7%
1/6 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
16.7%
1/6 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/12 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
10.0%
1/10 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/17 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
3.8%
2/52 • Number of events 3 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
5.9%
3/51 • Number of events 4 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
|
Investigations
Blood pressure increased
|
0.00%
0/12 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/10 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/17 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/52 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
2.0%
1/51 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
16.7%
1/6 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
|
Investigations
Brain natriuretic peptide increased
|
0.00%
0/12 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/10 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
5.9%
1/17 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/52 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/51 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
|
Investigations
Gamma-glutamyltransferase increased
|
8.3%
1/12 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
20.0%
2/10 • Number of events 3 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/17 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/52 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
5.9%
3/51 • Number of events 4 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
16.7%
1/6 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
|
Investigations
Glucose urine present
|
0.00%
0/12 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/10 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
5.9%
1/17 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/52 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/51 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/12 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/10 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/17 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/52 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/51 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
16.7%
1/6 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
|
Investigations
Liver function test abnormal
|
0.00%
0/12 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/10 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/17 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/52 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/51 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
16.7%
1/6 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
|
Investigations
Very low density lipoprotein increased
|
0.00%
0/12 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/10 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/17 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/52 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
3.9%
2/51 • Number of events 2 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/12 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/10 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/17 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
3.8%
2/52 • Number of events 2 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
11.8%
6/51 • Number of events 6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
8.3%
1/12 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/10 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/17 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/52 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
3.9%
2/51 • Number of events 2 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
|
Nervous system disorders
Headache
|
33.3%
4/12 • Number of events 4 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
20.0%
2/10 • Number of events 2 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
17.6%
3/17 • Number of events 3 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
25.0%
13/52 • Number of events 35 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
37.3%
19/51 • Number of events 30 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
33.3%
2/6 • Number of events 2 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
16.7%
1/6 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
|
Metabolism and nutrition disorders
Increased appetite
|
0.00%
0/12 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/10 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
5.9%
1/17 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/52 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/51 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.3%
1/12 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
20.0%
2/10 • Number of events 2 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/17 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
19.2%
10/52 • Number of events 13 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
17.6%
9/51 • Number of events 10 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
16.7%
1/6 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
16.7%
1/6 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
16.7%
2/12 • Number of events 2 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/10 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/17 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
7.7%
4/52 • Number of events 6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
13.7%
7/51 • Number of events 9 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
16.7%
1/6 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
16.7%
1/6 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
|
Musculoskeletal and connective tissue disorders
Exostosis
|
0.00%
0/12 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/10 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
5.9%
1/17 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/52 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/51 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
8.3%
1/12 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/10 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
5.9%
1/17 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
5.8%
3/52 • Number of events 3 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
15.7%
8/51 • Number of events 13 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
16.7%
1/6 • Number of events 2 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
8.3%
1/12 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/10 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/17 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/52 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/51 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
8.3%
1/12 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/10 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/17 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/52 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/51 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
8.3%
1/12 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/10 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/17 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/52 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
3.9%
2/51 • Number of events 2 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
16.7%
1/6 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
8.3%
1/12 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/10 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
11.8%
2/17 • Number of events 2 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
5.8%
3/52 • Number of events 4 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
2.0%
1/51 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
16.7%
1/6 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/12 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/10 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
5.9%
1/17 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
1.9%
1/52 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/51 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/12 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/10 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
5.9%
1/17 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
3.8%
2/52 • Number of events 2 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
3.9%
2/51 • Number of events 2 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
16.7%
1/6 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
8.3%
1/12 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/10 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
5.9%
1/17 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
5.8%
3/52 • Number of events 3 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/51 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
25.0%
3/12 • Number of events 3 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/10 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
5.9%
1/17 • Number of events 3 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
7.7%
4/52 • Number of events 4 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
2.0%
1/51 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
16.7%
1/6 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/12 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/10 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/17 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/52 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
3.9%
2/51 • Number of events 2 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
|
Nervous system disorders
Autonomic nervous system imbalance
|
0.00%
0/12 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/10 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/17 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/52 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/51 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
16.7%
1/6 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/12 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/10 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/17 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
11.5%
6/52 • Number of events 6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
5.9%
3/51 • Number of events 3 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/12 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/10 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/17 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
5.8%
3/52 • Number of events 3 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/51 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
|
Nervous system disorders
Migraine
|
0.00%
0/12 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/10 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/17 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
3.8%
2/52 • Number of events 2 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
2.0%
1/51 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
16.7%
1/6 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
|
Nervous system disorders
Muscle spasticity
|
0.00%
0/12 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/10 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/17 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/52 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
3.9%
2/51 • Number of events 2 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
16.7%
1/6 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/12 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/10 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/17 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/52 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
2.0%
1/51 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
16.7%
1/6 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
|
Nervous system disorders
Psychomotor hyperactivity
|
0.00%
0/12 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/10 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/17 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/52 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/51 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
16.7%
1/6 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/12 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/10 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/17 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/52 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
3.9%
2/51 • Number of events 2 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
|
Nervous system disorders
Tremor
|
0.00%
0/12 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/10 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/17 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
3.8%
2/52 • Number of events 2 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/51 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/12 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/10 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
5.9%
1/17 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
3.8%
2/52 • Number of events 2 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
2.0%
1/51 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
|
Psychiatric disorders
Depression
|
0.00%
0/12 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/10 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/17 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
5.8%
3/52 • Number of events 3 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
2.0%
1/51 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
|
Psychiatric disorders
Euphoric mood
|
0.00%
0/12 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/10 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/17 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/52 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/51 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
16.7%
1/6 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/12 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/10 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
5.9%
1/17 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
5.8%
3/52 • Number of events 4 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
5.9%
3/51 • Number of events 3 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
|
Renal and urinary disorders
Micturition urgency
|
0.00%
0/12 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/10 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/17 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
3.8%
2/52 • Number of events 2 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
2.0%
1/51 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
|
Renal and urinary disorders
Pollakiuria
|
8.3%
1/12 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/10 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/17 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/52 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
2.0%
1/51 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
16.7%
1/6 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
16.7%
1/6 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/12 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
10.0%
1/10 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/17 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/52 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
5.9%
3/51 • Number of events 7 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
16.7%
1/6 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/12 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/10 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/17 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/52 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
3.9%
2/51 • Number of events 2 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
|
Respiratory, thoracic and mediastinal disorders
Choking
|
0.00%
0/12 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/10 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
5.9%
1/17 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/52 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/51 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.3%
1/12 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
10.0%
1/10 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
5.9%
1/17 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
7.7%
4/52 • Number of events 4 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
11.8%
6/51 • Number of events 6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
16.7%
1/6 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
16.7%
1/6 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
8.3%
1/12 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/10 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/17 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/52 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
2.0%
1/51 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
25.0%
3/12 • Number of events 6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/10 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
11.8%
2/17 • Number of events 2 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
3.8%
2/52 • Number of events 2 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
3.9%
2/51 • Number of events 2 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/12 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/10 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
5.9%
1/17 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
5.8%
3/52 • Number of events 4 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
3.9%
2/51 • Number of events 2 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/12 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/10 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
5.9%
1/17 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
5.8%
3/52 • Number of events 3 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
17.6%
9/51 • Number of events 10 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
16.7%
1/6 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus hypersecretion
|
0.00%
0/12 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/10 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/17 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/52 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/51 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
16.7%
1/6 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
0.00%
0/12 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
10.0%
1/10 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/17 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
1.9%
1/52 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/51 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/12 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/10 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/17 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
1.9%
1/52 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/51 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
16.7%
1/6 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/12 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/10 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/17 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/52 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
3.9%
2/51 • Number of events 4 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/12 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/10 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/17 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/52 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
2.0%
1/51 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
16.7%
1/6 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/12 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/10 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/17 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/52 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/51 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
16.7%
1/6 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/12 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/10 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
5.9%
1/17 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/52 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/51 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/12 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/10 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/17 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
1.9%
1/52 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
3.9%
2/51 • Number of events 2 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/12 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/10 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/17 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/52 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
3.9%
2/51 • Number of events 2 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/12 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/10 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/17 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
3.8%
2/52 • Number of events 2 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/51 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
|
Skin and subcutaneous tissue disorders
Rash
|
8.3%
1/12 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/10 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/17 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
1.9%
1/52 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
2.0%
1/51 • Number of events 3 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
0.00%
0/12 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/10 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/17 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/52 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/51 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
16.7%
1/6 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/12 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/10 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/17 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/52 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
3.9%
2/51 • Number of events 2 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/12 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/10 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
5.9%
1/17 • Number of events 1 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/52 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/51 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
|
Vascular disorders
Haematoma
|
0.00%
0/12 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/10 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/17 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
5.8%
3/52 • Number of events 5 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/51 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
|
Vascular disorders
Hot flush
|
0.00%
0/12 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/10 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/17 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/52 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/51 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
16.7%
1/6 • Number of events 2 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/6 • 16 weeks for Part 1 and 52 weeks for Part 2
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Our agreement is subject to confidentiality but generally the PI can publish, for noncommercial purposes only, results and methods of the trial, but no other Sponsor Confidential Information. PI must give Sponsor no less than 60 days to review any manuscript for a proposed publication and must delay publication for up to an additional 90 days thereafter if Sponsor needs to file any patent application to protect any of Sponsor's intellectual property contained in the proposed publication.
- Publication restrictions are in place
Restriction type: OTHER