Trial Outcomes & Findings for NT0102 in the Treatment of Children With Attention Deficit Hyperactivity Disorder (ADHD) (NCT NCT01835548)
NCT ID: NCT01835548
Last Updated: 2018-01-17
Results Overview
The primary efficacy endpoint was derived from the SKAMP-Combined score calculated as the total score of all 13 items of the SKAMP-Combined score. The SKAMP-Combined score was obtained by summing up each item score where each item is rated on a 7-point impairment scale (0=normal to 6=maximal impairment) for a total possible score of 0 to 78. A lower score indicates less symptomatology (i.e., is better). The SKAMP was a rating scale that specifically measures the classroom manifestations of ADHD. The SKAMP ratings were completed for all subjects at baseline (pre-dose) and at 1, 3, 5, 7, 10, 12, and 13 hours post-dose on the classroom testing day (Visit 8). The primary analysis time point for the primary efficacy endpoint was the average of all post-dose SKAMP scores during the 13-hour period.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
87 participants
Primary outcome timeframe
Visit 8 (Day 42)
Results posted on
2018-01-17
Participant Flow
Participant milestones
| Measure |
NT0102
After the screening/washout period, all participants received study drug NT0102 once daily for 4 weeks during the dose optimization period. After completion of the dose optimization period, the optimized dose of the study drug was selected, and participants were to stay on that dose for 1 week (dose stabilization period). At the end of this period, participants were randomized to a treatment. Participants in this arm were given 20-60 mg of NT0102 as oral disintegrating tablet (ODT) once daily for one week during the double-blind treatment period.
|
Placebo
After the screening/washout period, all participants received study drug NT0102 once daily for 4 weeks during the dose optimization period. After completion of the dose optimization period, the optimized dose of the study drug was selected, and participants were to stay on that dose for 1 week (dose stabilization period). At the end of this period, participants were randomized to a treatment. Participants in this arm were given placebo as matching ODT once daily for one week during the double-blind treatment period.
|
All Participants
All participants in the study went through the screening/washout period, then received study drug NT0102 once daily for 4 weeks during the dose optimization period. After completion of the dose optimization period, the optimized dose of the study drug was selected, and participants stayed on that dose for 1 week during the dose stabilization period before randomization into the double-blind treatment period.
|
|---|---|---|---|
|
Screening/Washout Period
STARTED
|
0
|
0
|
87
|
|
Screening/Washout Period
COMPLETED
|
0
|
0
|
87
|
|
Screening/Washout Period
NOT COMPLETED
|
0
|
0
|
0
|
|
Dose Optimization Period
STARTED
|
0
|
0
|
87
|
|
Dose Optimization Period
COMPLETED
|
0
|
0
|
85
|
|
Dose Optimization Period
NOT COMPLETED
|
0
|
0
|
2
|
|
Dose Stabilization Period
STARTED
|
0
|
0
|
85
|
|
Dose Stabilization Period
COMPLETED
|
0
|
0
|
85
|
|
Dose Stabilization Period
NOT COMPLETED
|
0
|
0
|
0
|
|
Double-Blind Treatment Period
STARTED
|
44
|
41
|
0
|
|
Double-Blind Treatment Period
COMPLETED
|
44
|
39
|
0
|
|
Double-Blind Treatment Period
NOT COMPLETED
|
0
|
2
|
0
|
Reasons for withdrawal
| Measure |
NT0102
After the screening/washout period, all participants received study drug NT0102 once daily for 4 weeks during the dose optimization period. After completion of the dose optimization period, the optimized dose of the study drug was selected, and participants were to stay on that dose for 1 week (dose stabilization period). At the end of this period, participants were randomized to a treatment. Participants in this arm were given 20-60 mg of NT0102 as oral disintegrating tablet (ODT) once daily for one week during the double-blind treatment period.
|
Placebo
After the screening/washout period, all participants received study drug NT0102 once daily for 4 weeks during the dose optimization period. After completion of the dose optimization period, the optimized dose of the study drug was selected, and participants were to stay on that dose for 1 week (dose stabilization period). At the end of this period, participants were randomized to a treatment. Participants in this arm were given placebo as matching ODT once daily for one week during the double-blind treatment period.
|
All Participants
All participants in the study went through the screening/washout period, then received study drug NT0102 once daily for 4 weeks during the dose optimization period. After completion of the dose optimization period, the optimized dose of the study drug was selected, and participants stayed on that dose for 1 week during the dose stabilization period before randomization into the double-blind treatment period.
|
|---|---|---|---|
|
Dose Optimization Period
Adverse Event
|
0
|
0
|
1
|
|
Dose Optimization Period
Withdrawal by Subject
|
0
|
0
|
1
|
|
Double-Blind Treatment Period
Adverse Event
|
0
|
1
|
0
|
|
Double-Blind Treatment Period
Withdrawal by Subject
|
0
|
1
|
0
|
Baseline Characteristics
NT0102 in the Treatment of Children With Attention Deficit Hyperactivity Disorder (ADHD)
Baseline characteristics by cohort
| Measure |
NT0102
n=43 Participants
After the screening/washout period, all participants received study drug NT0102 once daily for 4 weeks during the dose optimization period. After completion of the dose optimization period, the optimized dose of the study drug was selected, and participants were to stay on that dose for 1 week (dose stabilization period). At the end of this period, participants were randomized to a treatment. Participants in this arm were given 20-60 mg of NT0102 as oral disintegrating tablet (ODT) once daily for one week during the double-blind treatment period.
|
Placebo
n=39 Participants
After the screening/washout period, all participants received study drug NT0102 once daily for 4 weeks during the dose optimization period. After completion of the dose optimization period, the optimized dose of the study drug was selected, and participants were to stay on that dose for 1 week (dose stabilization period). At the end of this period, participants were randomized to a treatment. Participants in this arm were given placebo as matching ODT once daily for one week during the double-blind treatment period.
|
Total
n=82 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
9.1 years
STANDARD_DEVIATION 1.86 • n=5 Participants
|
9.3 years
STANDARD_DEVIATION 1.64 • n=7 Participants
|
9.2 years
STANDARD_DEVIATION 1.75 • n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Visit 8 (Day 42)Population: The full analysis set (FAS) consisted of all participants randomized to treatment who had at least 1 post-dose SKAMP-Combined treatment assessment during the classroom testing session on Visit 8. Participants were analyzed as randomized.
The primary efficacy endpoint was derived from the SKAMP-Combined score calculated as the total score of all 13 items of the SKAMP-Combined score. The SKAMP-Combined score was obtained by summing up each item score where each item is rated on a 7-point impairment scale (0=normal to 6=maximal impairment) for a total possible score of 0 to 78. A lower score indicates less symptomatology (i.e., is better). The SKAMP was a rating scale that specifically measures the classroom manifestations of ADHD. The SKAMP ratings were completed for all subjects at baseline (pre-dose) and at 1, 3, 5, 7, 10, 12, and 13 hours post-dose on the classroom testing day (Visit 8). The primary analysis time point for the primary efficacy endpoint was the average of all post-dose SKAMP scores during the 13-hour period.
Outcome measures
| Measure |
Placebo
n=39 Participants
After the screening/washout period, all participants received study drug NT0102 once daily for 4 weeks during the dose optimization period. After completion of the dose optimization period, the optimized dose of the study drug was selected, and participants were to stay on that dose for 1 week (dose stabilization period). At the end of this period, participants were randomized to a treatment. Participants in this arm were given placebo as matching ODT once daily for one week during the double-blind treatment period.
|
NT0102
n=43 Participants
After the screening/washout period, all participants received study drug NT0102 once daily for 4 weeks during the dose optimization period. After completion of the dose optimization period, the optimized dose of the study drug was selected, and participants were to stay on that dose for 1 week (dose stabilization period). At the end of this period, participants were randomized to a treatment. Participants in this arm were given 20-60 mg of NT0102 as oral disintegrating tablet (ODT) once daily for one week during the double-blind treatment period.
|
Double-Blind Phase: NT0102
At the end of the stabilization period, participants were randomized to a treatment. Participants in this arm were given 20-60 mg of NT0102 as ODT once daily for one week during the double-blind treatment period.
|
|---|---|---|---|
|
Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) Score
|
24.3 score on a scale
Standard Deviation 9.47
|
17.3 score on a scale
Standard Deviation 7.48
|
—
|
SECONDARY outcome
Timeframe: Visit 8 (Day 42) at 1 hour (h), 3 h, 5 h, 7 h, 10 h, 12 h and 13 hPopulation: FAS consisted of all participants randomized to treatment who had at least 1 post-dose SKAMP-Combined treatment assessment during the classroom testing session on Visit 8. Participants were analyzed as randomized.
Onset of effect was defined as the first time point at which NT0102 separates from placebo on SKAMP-Combined scores. A separation was defined as a statistically significant difference at the 5% level of active drug over placebo. Data was collected separately for NT0102 and Placebo arms and is reported as a comparison analysis of the two arms. This assessment was collected on the full classroom day, Visit 8.
Outcome measures
| Measure |
Placebo
n=82 Participants
After the screening/washout period, all participants received study drug NT0102 once daily for 4 weeks during the dose optimization period. After completion of the dose optimization period, the optimized dose of the study drug was selected, and participants were to stay on that dose for 1 week (dose stabilization period). At the end of this period, participants were randomized to a treatment. Participants in this arm were given placebo as matching ODT once daily for one week during the double-blind treatment period.
|
NT0102
After the screening/washout period, all participants received study drug NT0102 once daily for 4 weeks during the dose optimization period. After completion of the dose optimization period, the optimized dose of the study drug was selected, and participants were to stay on that dose for 1 week (dose stabilization period). At the end of this period, participants were randomized to a treatment. Participants in this arm were given 20-60 mg of NT0102 as oral disintegrating tablet (ODT) once daily for one week during the double-blind treatment period.
|
Double-Blind Phase: NT0102
At the end of the stabilization period, participants were randomized to a treatment. Participants in this arm were given 20-60 mg of NT0102 as ODT once daily for one week during the double-blind treatment period.
|
|---|---|---|---|
|
Onset of Effect
|
1 hour
|
—
|
—
|
SECONDARY outcome
Timeframe: Visit 8 (Day 42) at 1 hour (h), 3 h, 5 h, 7 h, 10 h, 12 h and 13 hPopulation: FAS consisted of all participants randomized to treatment who had at least 1 post-dose SKAMP-Combined treatment assessment during the classroom testing session on Visit 8. Participants were analyzed as randomized.
Duration of effect was defined as the last time point at which NT0102 separates from placebo on SKAMP-Combined scores. A separation was defined as a statistically significant difference at the 5% level of active drug over placebo. Data was collected separately for NT0102 and Placebo arms, and is reported as a comparison analysis of the two arms. This assessment was collected on the full classroom day, Visit 8.
Outcome measures
| Measure |
Placebo
n=82 Participants
After the screening/washout period, all participants received study drug NT0102 once daily for 4 weeks during the dose optimization period. After completion of the dose optimization period, the optimized dose of the study drug was selected, and participants were to stay on that dose for 1 week (dose stabilization period). At the end of this period, participants were randomized to a treatment. Participants in this arm were given placebo as matching ODT once daily for one week during the double-blind treatment period.
|
NT0102
After the screening/washout period, all participants received study drug NT0102 once daily for 4 weeks during the dose optimization period. After completion of the dose optimization period, the optimized dose of the study drug was selected, and participants were to stay on that dose for 1 week (dose stabilization period). At the end of this period, participants were randomized to a treatment. Participants in this arm were given 20-60 mg of NT0102 as oral disintegrating tablet (ODT) once daily for one week during the double-blind treatment period.
|
Double-Blind Phase: NT0102
At the end of the stabilization period, participants were randomized to a treatment. Participants in this arm were given 20-60 mg of NT0102 as ODT once daily for one week during the double-blind treatment period.
|
|---|---|---|---|
|
Duration of Effect
|
12 hour
|
—
|
—
|
SECONDARY outcome
Timeframe: Visit 8 (Day 42)Population: The per-protocol set were a subset of the FAS consisting of those participants who satisfied all of the inclusion/exclusion criteria and who correctly received the treatment to which they were randomized.
The SKAMP Rating Scale was comprised of 2 behavioral subscales, including the "Attention" subscale (4 items). The SKAMP-Attention subscore evaluates concentration in the classroom and is obtained by summing up each item score where each item is rated on a 7-point impairment scale (0=normal to 6=maximal impairment) for total possible combined score of 0 to 24. A lower score indicates less symptomatology (i.e. is better). The SKAMP-Attention subscores were derived from 20 minutes of direct observations of participant behavior. Ratings were based on the frequency and quality of behaviors.
Outcome measures
| Measure |
Placebo
n=38 Participants
After the screening/washout period, all participants received study drug NT0102 once daily for 4 weeks during the dose optimization period. After completion of the dose optimization period, the optimized dose of the study drug was selected, and participants were to stay on that dose for 1 week (dose stabilization period). At the end of this period, participants were randomized to a treatment. Participants in this arm were given placebo as matching ODT once daily for one week during the double-blind treatment period.
|
NT0102
n=42 Participants
After the screening/washout period, all participants received study drug NT0102 once daily for 4 weeks during the dose optimization period. After completion of the dose optimization period, the optimized dose of the study drug was selected, and participants were to stay on that dose for 1 week (dose stabilization period). At the end of this period, participants were randomized to a treatment. Participants in this arm were given 20-60 mg of NT0102 as oral disintegrating tablet (ODT) once daily for one week during the double-blind treatment period.
|
Double-Blind Phase: NT0102
At the end of the stabilization period, participants were randomized to a treatment. Participants in this arm were given 20-60 mg of NT0102 as ODT once daily for one week during the double-blind treatment period.
|
|---|---|---|---|
|
The Average of the SKAMP-Attention Scores
|
12.2 score on a scale
Standard Deviation 4.20
|
9.4 score on a scale
Standard Deviation 3.42
|
—
|
SECONDARY outcome
Timeframe: Visit 8 (Day 42)Population: The Per-Protocol Set were a subset of the FAS consisting of those participants who satisfied all of the inclusion/exclusion criteria and who correctly received the treatment to which they were randomized.
The SKAMP Rating Scale is comprised of 2 behavioural subscales, including the "Deportment" subscale (4 items). The SKAMP-Deportment subscore evaluates behaviour in the classroom and is obtained by summing up each item score where each item is rated on a 7-point impairment scale (0=normal to 6=maximal impairment) for total possible combined score of 0 to 24. A lower score indicates less symptomatology (i.e. is better). The SKAMP-Attention subscores were derived from 20 minutes of direct observations of participant behaviour. Ratings were based on the frequency and quality of behaviours.
Outcome measures
| Measure |
Placebo
n=38 Participants
After the screening/washout period, all participants received study drug NT0102 once daily for 4 weeks during the dose optimization period. After completion of the dose optimization period, the optimized dose of the study drug was selected, and participants were to stay on that dose for 1 week (dose stabilization period). At the end of this period, participants were randomized to a treatment. Participants in this arm were given placebo as matching ODT once daily for one week during the double-blind treatment period.
|
NT0102
n=42 Participants
After the screening/washout period, all participants received study drug NT0102 once daily for 4 weeks during the dose optimization period. After completion of the dose optimization period, the optimized dose of the study drug was selected, and participants were to stay on that dose for 1 week (dose stabilization period). At the end of this period, participants were randomized to a treatment. Participants in this arm were given 20-60 mg of NT0102 as oral disintegrating tablet (ODT) once daily for one week during the double-blind treatment period.
|
Double-Blind Phase: NT0102
At the end of the stabilization period, participants were randomized to a treatment. Participants in this arm were given 20-60 mg of NT0102 as ODT once daily for one week during the double-blind treatment period.
|
|---|---|---|---|
|
The Average of the SKAMP-Deportment Scores
|
12.5 score on a scale
Standard Deviation 6.23
|
7.9 score on a scale
Standard Deviation 5.26
|
—
|
SECONDARY outcome
Timeframe: Visit 8 (Day 42)Population: FAS consisted of all participants randomized to treatment who had at least 1 post-dose SKAMP-Combined treatment assessment during the classroom testing session on Visit 8. Participants were analyzed as randomized.
The PERMP consisted of 400 math problems and was graded as number of problems "Attempted" (PERMP-A) and number of problems "Correct." (PERMP-C). It was an objective measure of performance during the classroom testing day.
Outcome measures
| Measure |
Placebo
n=39 Participants
After the screening/washout period, all participants received study drug NT0102 once daily for 4 weeks during the dose optimization period. After completion of the dose optimization period, the optimized dose of the study drug was selected, and participants were to stay on that dose for 1 week (dose stabilization period). At the end of this period, participants were randomized to a treatment. Participants in this arm were given placebo as matching ODT once daily for one week during the double-blind treatment period.
|
NT0102
n=43 Participants
After the screening/washout period, all participants received study drug NT0102 once daily for 4 weeks during the dose optimization period. After completion of the dose optimization period, the optimized dose of the study drug was selected, and participants were to stay on that dose for 1 week (dose stabilization period). At the end of this period, participants were randomized to a treatment. Participants in this arm were given 20-60 mg of NT0102 as oral disintegrating tablet (ODT) once daily for one week during the double-blind treatment period.
|
Double-Blind Phase: NT0102
At the end of the stabilization period, participants were randomized to a treatment. Participants in this arm were given 20-60 mg of NT0102 as ODT once daily for one week during the double-blind treatment period.
|
|---|---|---|---|
|
The Average of the Permanent Product Measure of Performance - Attempted (PERMP-A) Score
|
82.0 number of problems attempted
Standard Deviation 39.55
|
107.5 number of problems attempted
Standard Deviation 57.53
|
—
|
SECONDARY outcome
Timeframe: Visit 8 (Day 42)Population: FAS consisted of all participants randomized to treatment who had at least 1 post-dose SKAMP-Combined treatment assessment during the classroom testing session on Visit 8. Participants were analyzed as randomized.
The PERMP consisted of 400 math problems and was graded as number of problems "Attempted" (PERMP-A) and number of problems "Correct." (PERMP-C). It was an objective measure of performance during the classroom testing day.
Outcome measures
| Measure |
Placebo
n=39 Participants
After the screening/washout period, all participants received study drug NT0102 once daily for 4 weeks during the dose optimization period. After completion of the dose optimization period, the optimized dose of the study drug was selected, and participants were to stay on that dose for 1 week (dose stabilization period). At the end of this period, participants were randomized to a treatment. Participants in this arm were given placebo as matching ODT once daily for one week during the double-blind treatment period.
|
NT0102
n=43 Participants
After the screening/washout period, all participants received study drug NT0102 once daily for 4 weeks during the dose optimization period. After completion of the dose optimization period, the optimized dose of the study drug was selected, and participants were to stay on that dose for 1 week (dose stabilization period). At the end of this period, participants were randomized to a treatment. Participants in this arm were given 20-60 mg of NT0102 as oral disintegrating tablet (ODT) once daily for one week during the double-blind treatment period.
|
Double-Blind Phase: NT0102
At the end of the stabilization period, participants were randomized to a treatment. Participants in this arm were given 20-60 mg of NT0102 as ODT once daily for one week during the double-blind treatment period.
|
|---|---|---|---|
|
The Average of the Permanent Product Measure of Performance - Correct (PERMP-C) Score
|
78.6 number of problems correct
Standard Deviation 40.60
|
104.1 number of problems correct
Standard Deviation 58.27
|
—
|
SECONDARY outcome
Timeframe: Visit 9 (Day 43)Population: The safety population included all participants who took at least 1 dose of study drug.
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
Outcome measures
| Measure |
Placebo
n=87 Participants
After the screening/washout period, all participants received study drug NT0102 once daily for 4 weeks during the dose optimization period. After completion of the dose optimization period, the optimized dose of the study drug was selected, and participants were to stay on that dose for 1 week (dose stabilization period). At the end of this period, participants were randomized to a treatment. Participants in this arm were given placebo as matching ODT once daily for one week during the double-blind treatment period.
|
NT0102
n=41 Participants
After the screening/washout period, all participants received study drug NT0102 once daily for 4 weeks during the dose optimization period. After completion of the dose optimization period, the optimized dose of the study drug was selected, and participants were to stay on that dose for 1 week (dose stabilization period). At the end of this period, participants were randomized to a treatment. Participants in this arm were given 20-60 mg of NT0102 as oral disintegrating tablet (ODT) once daily for one week during the double-blind treatment period.
|
Double-Blind Phase: NT0102
n=44 Participants
At the end of the stabilization period, participants were randomized to a treatment. Participants in this arm were given 20-60 mg of NT0102 as ODT once daily for one week during the double-blind treatment period.
|
|---|---|---|---|
|
Number of Participants With Adverse Events
|
70 Participants
|
10 Participants
|
11 Participants
|
Adverse Events
Dose Optimization/Stabilization Phase
Serious events: 0 serious events
Other events: 70 other events
Deaths: 0 deaths
Double-Blind Phase: Placebo
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Double-Blind Phase: NT0102
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Dose Optimization/Stabilization Phase
n=87 participants at risk
All participants received study drug NT0102 once daily for 4 weeks during the dose optimization period. After completion of the dose optimization period, the optimized dose of the study drug was selected, and participants were to stay on that dose for 1 week (dose stabilization period).
|
Double-Blind Phase: Placebo
n=41 participants at risk
At the end of the stabilization period, participants were randomized to a treatment. Participants in this arm were given placebo as matching ODT once daily for one week during the double-blind treatment period.
|
Double-Blind Phase: NT0102
n=44 participants at risk
At the end of the stabilization period, participants were randomized to a treatment. Participants in this arm were given 20-60 mg of NT0102 as ODT once daily for one week during the double-blind treatment period.
|
|---|---|---|---|
|
Cardiac disorders
Ventricular arrhythmia
|
1.1%
1/87 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
0.00%
0/41 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
0.00%
0/44 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
|
Ear and labyrinth disorders
Ear pain
|
1.1%
1/87 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
0.00%
0/41 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
0.00%
0/44 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
|
Eye disorders
Dry eye
|
2.3%
2/87 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
0.00%
0/41 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
0.00%
0/44 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
|
Eye disorders
Myopia
|
1.1%
1/87 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
0.00%
0/41 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
0.00%
0/44 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
21.8%
19/87 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
0.00%
0/41 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
0.00%
0/44 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
|
Gastrointestinal disorders
Constipation
|
3.4%
3/87 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
0.00%
0/41 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
0.00%
0/44 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
|
Gastrointestinal disorders
Diarrhoea
|
1.1%
1/87 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
0.00%
0/41 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
0.00%
0/44 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
|
Gastrointestinal disorders
Dyspepsia
|
1.1%
1/87 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
0.00%
0/41 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
0.00%
0/44 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
|
Gastrointestinal disorders
Oral pain
|
1.1%
1/87 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
0.00%
0/41 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
0.00%
0/44 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
|
Gastrointestinal disorders
Retching
|
1.1%
1/87 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
0.00%
0/41 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
0.00%
0/44 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
|
Gastrointestinal disorders
Vomiting
|
5.7%
5/87 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
0.00%
0/41 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
0.00%
0/44 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
|
General disorders
Fatigue
|
2.3%
2/87 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
0.00%
0/41 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
0.00%
0/44 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
|
General disorders
Irritability
|
6.9%
6/87 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
0.00%
0/41 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
0.00%
0/44 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
|
General disorders
Pyrexia
|
1.1%
1/87 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
0.00%
0/41 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
0.00%
0/44 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
|
Infections and infestations
Bronchitis
|
0.00%
0/87 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
2.4%
1/41 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
0.00%
0/44 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
|
Infections and infestations
Gastroenteritis viral
|
1.1%
1/87 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
0.00%
0/41 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
0.00%
0/44 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
|
Infections and infestations
Influenza
|
1.1%
1/87 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
2.4%
1/41 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
0.00%
0/44 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/87 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
2.4%
1/41 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
0.00%
0/44 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
|
Infections and infestations
Otitis media
|
1.1%
1/87 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
0.00%
0/41 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
0.00%
0/44 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
|
Infections and infestations
Pharyngitis streptococcal
|
1.1%
1/87 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
0.00%
0/41 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
0.00%
0/44 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
|
Infections and infestations
Upper respiratory tract infection
|
11.5%
10/87 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
7.3%
3/41 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
9.1%
4/44 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
2.3%
2/87 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
0.00%
0/41 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
0.00%
0/44 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
|
Injury, poisoning and procedural complications
Burns second degree
|
0.00%
0/87 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
0.00%
0/41 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
2.3%
1/44 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
|
Injury, poisoning and procedural complications
Excoriation
|
1.1%
1/87 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
4.9%
2/41 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
0.00%
0/44 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
|
Injury, poisoning and procedural complications
Laceration
|
1.1%
1/87 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
0.00%
0/41 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
0.00%
0/44 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/87 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
2.4%
1/41 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
0.00%
0/44 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
|
Injury, poisoning and procedural complications
Muscle strain
|
1.1%
1/87 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
0.00%
0/41 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
0.00%
0/44 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
|
Injury, poisoning and procedural complications
Periorbital haematoma
|
1.1%
1/87 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
0.00%
0/41 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
0.00%
0/44 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/87 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
0.00%
0/41 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
2.3%
1/44 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
|
Investigations
Blood pressure increased
|
1.1%
1/87 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
0.00%
0/41 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
0.00%
0/44 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
|
Investigations
Liver function test abnormal
|
0.00%
0/87 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
2.4%
1/41 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
0.00%
0/44 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
|
Investigations
Weight decreased
|
1.1%
1/87 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
0.00%
0/41 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
0.00%
0/44 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
|
Investigations
Weight increased
|
1.1%
1/87 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
0.00%
0/41 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
0.00%
0/44 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
26.4%
23/87 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
0.00%
0/41 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
0.00%
0/44 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
|
Metabolism and nutrition disorders
Polydipsia
|
1.1%
1/87 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
0.00%
0/41 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
0.00%
0/44 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.1%
1/87 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
0.00%
0/41 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
0.00%
0/44 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.1%
1/87 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
0.00%
0/41 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
0.00%
0/44 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/87 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
2.4%
1/41 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
0.00%
0/44 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
|
Nervous system disorders
Dizziness
|
1.1%
1/87 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
0.00%
0/41 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
2.3%
1/44 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
|
Nervous system disorders
Dysgeusia
|
4.6%
4/87 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
0.00%
0/41 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
0.00%
0/44 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
|
Nervous system disorders
Headache
|
19.5%
17/87 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
2.4%
1/41 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
2.3%
1/44 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
|
Nervous system disorders
Migraine
|
1.1%
1/87 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
0.00%
0/41 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
0.00%
0/44 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
|
Nervous system disorders
Somnolence
|
3.4%
3/87 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
0.00%
0/41 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
0.00%
0/44 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
|
Nervous system disorders
Tremor
|
1.1%
1/87 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
0.00%
0/41 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
0.00%
0/44 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
|
Psychiatric disorders
Affect lability
|
9.2%
8/87 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
0.00%
0/41 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
0.00%
0/44 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
|
Psychiatric disorders
Emotional disorder
|
1.1%
1/87 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
0.00%
0/41 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
0.00%
0/44 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
|
Psychiatric disorders
Initial insomnia
|
2.3%
2/87 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
0.00%
0/41 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
0.00%
0/44 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
|
Psychiatric disorders
Insomnia
|
12.6%
11/87 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
0.00%
0/41 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
0.00%
0/44 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
|
Psychiatric disorders
Middle insomnia
|
1.1%
1/87 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
0.00%
0/41 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
0.00%
0/44 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
|
Psychiatric disorders
Negativism
|
1.1%
1/87 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
0.00%
0/41 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
0.00%
0/44 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
|
Psychiatric disorders
Tic
|
2.3%
2/87 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
0.00%
0/41 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
0.00%
0/44 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
|
Psychiatric disorders
Trichotillomania
|
0.00%
0/87 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
0.00%
0/41 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
2.3%
1/44 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.7%
5/87 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
0.00%
0/41 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
2.3%
1/44 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.1%
1/87 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
0.00%
0/41 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
0.00%
0/44 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/87 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
0.00%
0/41 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
2.3%
1/44 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
1.1%
1/87 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
0.00%
0/41 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
0.00%
0/44 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.1%
1/87 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
0.00%
0/41 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
0.00%
0/44 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.1%
1/87 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
0.00%
0/41 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
0.00%
0/44 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
1.1%
1/87 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
0.00%
0/41 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
0.00%
0/44 • Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60