Trial Outcomes & Findings for Brivaracetam as add-on Treatment of Unverricht-Lundborg Disease (ULD) in Adolescents and Adults (NCT NCT00368251)
NCT ID: NCT00368251
Last Updated: 2023-05-31
Results Overview
The range for Action Myoclonus Score (centrally read) is 0 (best) - 160 (worst). Percent change from Baseline = 100 X ((Baseline UMRS4 - Treatment UMRS4) / Baseline UMRS4). Baseline is defined as the last non-missing value prior to or on Randomization Visit.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
56 participants
Primary outcome timeframe
From Baseline to End of Treatment Period (Week 14 or Early Discontinuation Visit)
Results posted on
2023-05-31
Participant Flow
72 subjects were screened, 56 subjects were randomized. Participant Flow refers to all subjects randomized who are identical with the Intent-To-Treat (ITT) Population, which consists of all randomized subjects who took at least one dose of study medication.
Participant milestones
| Measure |
Placebo
Placebo twice a day (bid), 14 weeks (2 week Up-Titration Period + 12 week Maintenance Period)
|
Brivaracetam 5 mg/Day
Brivaracetam (BRV) 5 mg/day 2.5 mg twice a day (bid) using 2.5 mg tablets for 12 weeks (after 2 week Up- Titration Period)
|
Brivaracetam 150 mg/Day
Brivaracetam (BRV) 150 mg/day 75 mg twice a day (bid) using 25 mg and 50 mg tablets for 12 weeks (after 2 week Up-Titration Period)
|
|---|---|---|---|
|
Overall Study
STARTED
|
18
|
20
|
18
|
|
Overall Study
COMPLETED
|
17
|
20
|
17
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
1
|
Reasons for withdrawal
| Measure |
Placebo
Placebo twice a day (bid), 14 weeks (2 week Up-Titration Period + 12 week Maintenance Period)
|
Brivaracetam 5 mg/Day
Brivaracetam (BRV) 5 mg/day 2.5 mg twice a day (bid) using 2.5 mg tablets for 12 weeks (after 2 week Up- Titration Period)
|
Brivaracetam 150 mg/Day
Brivaracetam (BRV) 150 mg/day 75 mg twice a day (bid) using 25 mg and 50 mg tablets for 12 weeks (after 2 week Up-Titration Period)
|
|---|---|---|---|
|
Overall Study
SAE, non-fatal
|
1
|
0
|
0
|
|
Overall Study
AE, non-serious non-fatal
|
0
|
0
|
1
|
Baseline Characteristics
Brivaracetam as add-on Treatment of Unverricht-Lundborg Disease (ULD) in Adolescents and Adults
Baseline characteristics by cohort
| Measure |
Placebo
n=18 Participants
Placebo twice a day (bid), 14 weeks (2 week Up-Titration Period + 12 week Maintenance Period)
|
Brivaracetam 5 mg/Day
n=20 Participants
Brivaracetam (BRV) 5 mg/day 2.5 mg twice a day (bid) using 2.5 mg tablets for 12 weeks (after 2 week Up- Titration Period)
|
Brivaracetam 150 mg/Day
n=18 Participants
Brivaracetam (BRV) 150 mg/day 75 mg twice a day (bid) using 25 mg and 50 mg tablets for 12 weeks (after 2 week Up-Titration Period)
|
Total Title
n=56 Participants
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
18 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
54 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Continuous
|
34.3 years
STANDARD_DEVIATION 9.2 • n=5 Participants
|
35.8 years
STANDARD_DEVIATION 10.9 • n=7 Participants
|
33.7 years
STANDARD_DEVIATION 11.4 • n=5 Participants
|
34.65 years
STANDARD_DEVIATION 10.38 • n=4 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
|
Region of Enrollment
Serbia
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
6 participants
n=4 Participants
|
|
Region of Enrollment
France
|
3 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
8 participants
n=4 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=5 Participants
|
3 participants
n=7 Participants
|
4 participants
n=5 Participants
|
9 participants
n=4 Participants
|
|
Region of Enrollment
Canada
|
4 participants
n=5 Participants
|
3 participants
n=7 Participants
|
2 participants
n=5 Participants
|
9 participants
n=4 Participants
|
|
Region of Enrollment
Finland
|
3 participants
n=5 Participants
|
4 participants
n=7 Participants
|
2 participants
n=5 Participants
|
9 participants
n=4 Participants
|
|
Region of Enrollment
Russian Federation
|
2 participants
n=5 Participants
|
3 participants
n=7 Participants
|
3 participants
n=5 Participants
|
8 participants
n=4 Participants
|
|
Region of Enrollment
Israel
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
2 participants
n=4 Participants
|
|
Region of Enrollment
Tunisia
|
2 participants
n=5 Participants
|
3 participants
n=7 Participants
|
0 participants
n=5 Participants
|
5 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: From Baseline to End of Treatment Period (Week 14 or Early Discontinuation Visit)Population: The number of subjects is equal to the number of subjects in the Intent-To-Treat (ITT) population having non-missing post-baseline results for the percent change from baseline on the functional disability score (UMRS section 5). In case a subject drops out, the result at Early Discontinuation Visit is used.
The range for Action Myoclonus Score (centrally read) is 0 (best) - 160 (worst). Percent change from Baseline = 100 X ((Baseline UMRS4 - Treatment UMRS4) / Baseline UMRS4). Baseline is defined as the last non-missing value prior to or on Randomization Visit.
Outcome measures
| Measure |
Placebo
n=18 Participants
Placebo twice a day (bid), 14 weeks (2 week Up-Titration Period + 12 week Maintenance Period)
|
Brivaracetam 5 mg/Day
n=20 Participants
Brivaracetam (BRV) 5 mg/day 2.5 mg twice a day (bid) using 2.5 mg tablets for 12 weeks (after 2 week Up- Titration Period)
|
Brivaracetam 150 mg/Day
n=18 Participants
Brivaracetam (BRV) 150 mg/day 75 mg twice a day (bid) using 25 mg and 50 mg tablets for 12 weeks (after 2 week Up-Titration Period)
|
|---|---|---|---|
|
Percent Change From Baseline to the End of Treatment Period on the Action Myoclonus Score (Unified Myoclonus Rating Scale (UMRS) Section 4)
|
17.45 Percent change
Interval -170.0 to 61.5
|
-4.60 Percent change
Interval -430.0 to 81.8
|
12.34 Percent change
Interval -58.3 to 96.9
|
SECONDARY outcome
Timeframe: Baseline to End of Treatment Period (Week 14 or Early Discontinuation Visit)Population: The number of subjects is equal to the number of subjects in the Intent-To-Treat (ITT) population having non-missing post-baseline results for the percent change from baseline on the functional disability score (UMRS section 5). In case a subject drops out, the result at Early Discontinuation Visit is used.
The range for Functional Disability Score is 0 (best) to 28 (worst). Percent change from Baseline = 100 X ((Baseline UMRS5 - Treatment UMRS5) / Baseline UMRS5). Baseline is defined as the last non-missing value prior to or on Randomization Visit.
Outcome measures
| Measure |
Placebo
n=18 Participants
Placebo twice a day (bid), 14 weeks (2 week Up-Titration Period + 12 week Maintenance Period)
|
Brivaracetam 5 mg/Day
n=20 Participants
Brivaracetam (BRV) 5 mg/day 2.5 mg twice a day (bid) using 2.5 mg tablets for 12 weeks (after 2 week Up- Titration Period)
|
Brivaracetam 150 mg/Day
n=18 Participants
Brivaracetam (BRV) 150 mg/day 75 mg twice a day (bid) using 25 mg and 50 mg tablets for 12 weeks (after 2 week Up-Titration Period)
|
|---|---|---|---|
|
Percent Change From Baseline to the End of Treatment Period on the Functional Disability Score (Unified Myoclonus Rating Scale (UMRS) Section 5)
|
0.00 Percent change
Interval -380.0 to 53.8
|
0.00 Percent change
Interval -380.0 to 60.0
|
0.00 Percent change
Interval -85.7 to 75.0
|
SECONDARY outcome
Timeframe: Baseline to End of Treatment Period (Week 14 or Early Discontinuation Visit)Population: The number of subjects is equal to the number of subjects in the Intent-To-Treat (ITT) population having non-missing post-baseline results for the percent change from baseline on the stimulus sensitivity score (UMRS section 3). In case a subject drops out, the result at Early Discontinuation Visit (EDV) is used.
The range for Stimulus Sensitivity Score is 0 (best) to 17 (worst). Percent change from Baseline = 100 X ((Baseline UMRS3 - Treatment UMRS3) / Baseline UMRS3). Baseline is defined as the last non-missing value prior to or on Randomization Visit.
Outcome measures
| Measure |
Placebo
n=18 Participants
Placebo twice a day (bid), 14 weeks (2 week Up-Titration Period + 12 week Maintenance Period)
|
Brivaracetam 5 mg/Day
n=20 Participants
Brivaracetam (BRV) 5 mg/day 2.5 mg twice a day (bid) using 2.5 mg tablets for 12 weeks (after 2 week Up- Titration Period)
|
Brivaracetam 150 mg/Day
n=18 Participants
Brivaracetam (BRV) 150 mg/day 75 mg twice a day (bid) using 25 mg and 50 mg tablets for 12 weeks (after 2 week Up-Titration Period)
|
|---|---|---|---|
|
Percent Change From Baseline to the End of Treatment Period on the Stimulus Sensitivity Score (Unified Myoclonus Rating Scale (UMRS) Section 3)
|
0.00 Percent change
Interval -300.0 to 100.0
|
43.44 Percent change
Interval -300.0 to 100.0
|
0.00 Percent change
Interval -300.0 to 100.0
|
SECONDARY outcome
Timeframe: Baseline to End of Treatment Period (Week 14 or Early Discontinuation Visit)Population: The number of subjects is equal to the number of subjects in the Intent-To-Treat (ITT) population having non-missing post-baseline results for the percent change from baseline on the Myoclonus Patient Questionnaire (UMRS section 1). In case a subject drops out, the result at Early Discontinuation Visit (EDV) is used.
The range for Myoclonus Patient Questionnaire is 0 (best) to 44 (worst). Percent change from Baseline = 100 X ((Baseline UMRS1 - Treatment UMRS1) / Baseline UMRS1). Baseline is defined as the last non-missing value prior to or on Randomization Visit.
Outcome measures
| Measure |
Placebo
n=17 Participants
Placebo twice a day (bid), 14 weeks (2 week Up-Titration Period + 12 week Maintenance Period)
|
Brivaracetam 5 mg/Day
n=20 Participants
Brivaracetam (BRV) 5 mg/day 2.5 mg twice a day (bid) using 2.5 mg tablets for 12 weeks (after 2 week Up- Titration Period)
|
Brivaracetam 150 mg/Day
n=18 Participants
Brivaracetam (BRV) 150 mg/day 75 mg twice a day (bid) using 25 mg and 50 mg tablets for 12 weeks (after 2 week Up-Titration Period)
|
|---|---|---|---|
|
Percent Change From Baseline to the End of Treatment Period on the Myoclonus Patient Questionnaire (Unified Myoclonus Rating Scale (UMRS) Section 1)
|
-9.68 Percent change
Interval -125.0 to 63.0
|
0.00 Percent change
Interval -95.0 to 55.6
|
5.41 Percent change
Interval -24.0 to 100.0
|
SECONDARY outcome
Timeframe: End of Treatment Period (Week 14 or Early Discontinuation Visit)Population: The number of subjects is equal to the number of subjects in the Intent-To-Treat (ITT) population having non-missing post-baseline results for the Global Evaluation Score (I-GES). In case a subject drops out, the result at Early Discontinuation Visit (EDV) is used.
The Global Evaluation Scale Score (Investigator) ranges from 1 (Marked worsening) to 7 (Marked improvement).
Outcome measures
| Measure |
Placebo
n=18 Participants
Placebo twice a day (bid), 14 weeks (2 week Up-Titration Period + 12 week Maintenance Period)
|
Brivaracetam 5 mg/Day
n=20 Participants
Brivaracetam (BRV) 5 mg/day 2.5 mg twice a day (bid) using 2.5 mg tablets for 12 weeks (after 2 week Up- Titration Period)
|
Brivaracetam 150 mg/Day
n=18 Participants
Brivaracetam (BRV) 150 mg/day 75 mg twice a day (bid) using 25 mg and 50 mg tablets for 12 weeks (after 2 week Up-Titration Period)
|
|---|---|---|---|
|
Global Evaluation Score (Investigator) at the End of Treatment Period
Moderate worsening
|
0 percentage of participants
|
0 percentage of participants
|
5.6 percentage of participants
|
|
Global Evaluation Score (Investigator) at the End of Treatment Period
Marked improvement
|
0 percentage of participants
|
10.0 percentage of participants
|
11.1 percentage of participants
|
|
Global Evaluation Score (Investigator) at the End of Treatment Period
Moderate improvement
|
11.1 percentage of participants
|
0 percentage of participants
|
11.1 percentage of participants
|
|
Global Evaluation Score (Investigator) at the End of Treatment Period
Slight improvement
|
33.3 percentage of participants
|
30.0 percentage of participants
|
33.3 percentage of participants
|
|
Global Evaluation Score (Investigator) at the End of Treatment Period
No change
|
50.0 percentage of participants
|
50.0 percentage of participants
|
33.3 percentage of participants
|
|
Global Evaluation Score (Investigator) at the End of Treatment Period
Slight worsening
|
0 percentage of participants
|
10.0 percentage of participants
|
5.6 percentage of participants
|
|
Global Evaluation Score (Investigator) at the End of Treatment Period
Marked worsening
|
5.6 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
Adverse Events
Placebo
Serious events: 2 serious events
Other events: 13 other events
Deaths: 0 deaths
Brivaracetam 5 mg/Day
Serious events: 3 serious events
Other events: 13 other events
Deaths: 0 deaths
Brivaracetam 150 mg/Day
Serious events: 2 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=18 participants at risk
Placebo twice a day (bid), 14 weeks (2 week Up-Titration Period + 12 week Maintenance Period)
|
Brivaracetam 5 mg/Day
n=20 participants at risk
Brivaracetam (BRV) 5 mg/day 2.5 mg twice a day (bid) using 2.5 mg tablets for 12 weeks (after 2 week Up- Titration Period)
|
Brivaracetam 150 mg/Day
n=18 participants at risk
Brivaracetam (BRV) 150 mg/day 75 mg twice a day (bid) using 25 mg and 50 mg tablets for 12 weeks (after 2 week Up-Titration Period)
|
|---|---|---|---|
|
General disorders
Pyrexia
|
5.6%
1/18 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/18 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
10.0%
2/20 • Number of events 2 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/18 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
|
Nervous system disorders
Convulsion
|
5.6%
1/18 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
5.0%
1/20 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
|
Nervous system disorders
Grand mal convulsion
|
0.00%
0/18 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
|
Nervous system disorders
Status epilepticus
|
0.00%
0/18 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
|
Nervous system disorders
Myoclonic epilepsy
|
5.6%
1/18 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
|
Psychiatric disorders
Attention-seeking behavior
|
5.6%
1/18 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
Other adverse events
| Measure |
Placebo
n=18 participants at risk
Placebo twice a day (bid), 14 weeks (2 week Up-Titration Period + 12 week Maintenance Period)
|
Brivaracetam 5 mg/Day
n=20 participants at risk
Brivaracetam (BRV) 5 mg/day 2.5 mg twice a day (bid) using 2.5 mg tablets for 12 weeks (after 2 week Up- Titration Period)
|
Brivaracetam 150 mg/Day
n=18 participants at risk
Brivaracetam (BRV) 150 mg/day 75 mg twice a day (bid) using 25 mg and 50 mg tablets for 12 weeks (after 2 week Up-Titration Period)
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Shoulder pain
|
5.6%
1/18 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
|
Blood and lymphatic system disorders
Granulocytopenia
|
0.00%
0/18 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/18 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/18 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 2 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/18 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
|
Cardiac disorders
Electrocardiogram QT corrected interval prolonged
|
5.6%
1/18 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
|
Ear and labyrinth disorders
Tinnitus
|
5.6%
1/18 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
5.0%
1/20 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
|
Ear and labyrinth disorders
Middle ear inflammation
|
5.6%
1/18 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
|
Gastrointestinal disorders
Nausea
|
5.6%
1/18 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
10.0%
2/20 • Number of events 2 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
11.1%
2/18 • Number of events 2 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
10.0%
2/20 • Number of events 2 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
|
Gastrointestinal disorders
Diarrhoea
|
11.1%
2/18 • Number of events 3 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
5.0%
1/20 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
|
Gastrointestinal disorders
Abdominal pain
|
5.6%
1/18 • Number of events 3 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
|
Gastrointestinal disorders
Constipation
|
11.1%
2/18 • Number of events 2 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/18 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/18 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
5.6%
1/18 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
|
General disorders
Fatigue
|
11.1%
2/18 • Number of events 2 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
5.0%
1/20 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
16.7%
3/18 • Number of events 6 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
|
General disorders
Oedema peripheral
|
5.6%
1/18 • Number of events 2 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
|
General disorders
Pyrexia
|
5.6%
1/18 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
|
Hepatobiliary disorders
Hepatomegaly
|
0.00%
0/18 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
|
Infections and infestations
Nasopharyngitis
|
16.7%
3/18 • Number of events 4 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
5.0%
1/20 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
|
Infections and infestations
Respiratory tract infection viral
|
0.00%
0/18 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
5.0%
1/20 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 3 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
|
Infections and infestations
Gastrointestinal infection
|
0.00%
0/18 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
5.6%
1/18 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
5.0%
1/20 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
|
Infections and infestations
Gastroenteritis
|
5.6%
1/18 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
|
Infections and infestations
Otitis externa
|
11.1%
2/18 • Number of events 3 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
|
Infections and infestations
Pharyngitis
|
5.6%
1/18 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
|
Infections and infestations
Sinusitis
|
5.6%
1/18 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
|
Infections and infestations
Urinary tract infection
|
11.1%
2/18 • Number of events 2 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/18 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/18 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/18 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Joint sprain
|
5.6%
1/18 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Weight decreased
|
0.00%
0/18 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
5.0%
1/20 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Anorexia
|
5.6%
1/18 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Increased appetite
|
5.6%
1/18 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Weight increased
|
5.6%
1/18 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
5.6%
1/18 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
5.0%
1/20 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.6%
1/18 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 2 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/18 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.6%
1/18 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
5.0%
1/20 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/18 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 2 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
|
Nervous system disorders
Myoclonus
|
5.6%
1/18 • Number of events 2 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
20.0%
4/20 • Number of events 4 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
16.7%
3/18 • Number of events 4 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
|
Nervous system disorders
Somnolence
|
11.1%
2/18 • Number of events 2 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
15.0%
3/20 • Number of events 3 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
22.2%
4/18 • Number of events 7 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
|
Nervous system disorders
Headache
|
38.9%
7/18 • Number of events 8 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
15.0%
3/20 • Number of events 4 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
11.1%
2/18 • Number of events 2 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/18 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
5.0%
1/20 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
11.1%
2/18 • Number of events 4 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
|
Nervous system disorders
Dizziness
|
11.1%
2/18 • Number of events 2 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
5.0%
1/20 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
|
Nervous system disorders
Grand mal convulsion
|
0.00%
0/18 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
10.0%
2/20 • Number of events 2 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
|
Nervous system disorders
Hyporeflexia
|
0.00%
0/18 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
11.1%
2/18 • Number of events 2 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
|
Nervous system disorders
Complex partial seizures
|
0.00%
0/18 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
|
Nervous system disorders
Coordination abnormal
|
0.00%
0/18 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
|
Nervous system disorders
Dysarthria
|
5.6%
1/18 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 2 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
|
Nervous system disorders
Migraine
|
0.00%
0/18 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 3 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
|
Nervous system disorders
Nystagmus
|
0.00%
0/18 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
|
Nervous system disorders
Tremor
|
16.7%
3/18 • Number of events 4 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
|
Nervous system disorders
Convulsion
|
5.6%
1/18 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
|
Nervous system disorders
Myoclonic epilepsy
|
5.6%
1/18 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
|
Nervous system disorders
Sciatica
|
5.6%
1/18 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
|
Psychiatric disorders
Aggression
|
5.6%
1/18 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
10.0%
2/20 • Number of events 2 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
|
Psychiatric disorders
Insomnia
|
11.1%
2/18 • Number of events 2 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
10.0%
2/20 • Number of events 2 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
|
Psychiatric disorders
Anxiety
|
5.6%
1/18 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
|
Psychiatric disorders
Depression
|
5.6%
1/18 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
5.0%
1/20 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
|
Psychiatric disorders
Bradyphrenia
|
5.6%
1/18 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
|
Psychiatric disorders
Depressed mood
|
5.6%
1/18 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
|
Psychiatric disorders
Disorientation
|
5.6%
1/18 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
|
Psychiatric disorders
Memory impairment
|
5.6%
1/18 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
|
Renal and urinary disorders
Enuresis
|
0.00%
0/18 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
|
Renal and urinary disorders
Pollakiuria
|
5.6%
1/18 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
|
Reproductive system and breast disorders
Genital pruritus female
|
5.6%
1/18 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/18 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/18 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract congestion
|
0.00%
0/18 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/18 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
0.00%
0/18 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.6%
1/18 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
5.6%
1/18 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
5.6%
1/18 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
|
Vascular disorders
Haematoma
|
5.6%
1/18 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
|
Additional Information
UCB Cares
UCB
Phone: +1877 822
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60