Trial Outcomes & Findings for A Study to Evaluate ALKS 5461 in Subjects With Major Depressive Disorder (MDD) (NCT NCT01500200)
NCT ID: NCT01500200
Last Updated: 2019-05-21
Results Overview
The HAM-D17 scale is a clinician-administered questionnaire comprised of 17 items used to measure the severity of MDD symptoms. Scores range from 0 (no apparent symptoms) to 50 (most severe symptoms). Individual questionnaire items include depressed mood, work and activities, insomnia (early), insomnia (middle), insomnia (late), genital symptoms, somatic symptoms (gastrointestinal), loss of weight, somatic symptoms (general), feelings of guilt, suicide, anxiety (psychic), anxiety (somatic), hypochondriasis, insight, agitation, and retardation.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
142 participants
Primary outcome timeframe
Baseline and 4 weeks for each stage
Results posted on
2019-05-21
Participant Flow
Subjects were diagnosed with major depressive disorder (MDD) and had an inadequate response to 1 or 2 adequate courses of treatment with a commercially available antidepressant therapy (ADT) during the current major depressive episode (MDE). All subjects continued ADT for the duration of the study.
This was a Sequential Parallel Comparison Design (SPCD) study comprised of 2 stages. In Stage 1 subjects were randomized to ALKS 5461 or placebo (2:2:9). In Stage 2 only placebo non-responders from Stage 1 were re-randomized to ALKS 5461 or placebo (1:1:1). One subject randomized to placebo did not receive study drug.
Participant milestones
| Measure |
Placebo S1
Received placebo in Stage 1
|
ALKS 5461 2mg/2mg S1
Received ALKS 5461 2mg/2mg in Stage 1
|
ALKS 5461 8mg/8mg S1
Received ALKS 5461 8mg/8mg in Stage 1
|
Placebo S2
Received placebo in Stage 2
|
ALKS 5461 2mg/2mg S2
Received ALKS 5461 2mg/2mg in Stage 2
|
ALKS 5461 8mg/8mg S2
Received ALKS 5461 8mg/8mg in Stage 2
|
|---|---|---|---|---|---|---|
|
Stage 1
STARTED
|
98
|
24
|
19
|
0
|
0
|
0
|
|
Stage 1
COMPLETED
|
90
|
18
|
13
|
0
|
0
|
0
|
|
Stage 1
NOT COMPLETED
|
8
|
6
|
6
|
0
|
0
|
0
|
|
Stage 2
STARTED
|
0
|
0
|
0
|
20
|
23
|
22
|
|
Stage 2
COMPLETED
|
0
|
0
|
0
|
20
|
18
|
18
|
|
Stage 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
5
|
4
|
Reasons for withdrawal
| Measure |
Placebo S1
Received placebo in Stage 1
|
ALKS 5461 2mg/2mg S1
Received ALKS 5461 2mg/2mg in Stage 1
|
ALKS 5461 8mg/8mg S1
Received ALKS 5461 8mg/8mg in Stage 1
|
Placebo S2
Received placebo in Stage 2
|
ALKS 5461 2mg/2mg S2
Received ALKS 5461 2mg/2mg in Stage 2
|
ALKS 5461 8mg/8mg S2
Received ALKS 5461 8mg/8mg in Stage 2
|
|---|---|---|---|---|---|---|
|
Stage 1
Adverse Event
|
1
|
4
|
5
|
0
|
0
|
0
|
|
Stage 1
Lost to Follow-up
|
2
|
2
|
1
|
0
|
0
|
0
|
|
Stage 1
Withdrawal by Subject
|
3
|
0
|
0
|
0
|
0
|
0
|
|
Stage 1
Noncompliance with Study Drug
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Stage 1
Physician Decision
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Stage 2
Adverse Event
|
0
|
0
|
0
|
0
|
5
|
4
|
Baseline Characteristics
A Study to Evaluate ALKS 5461 in Subjects With Major Depressive Disorder (MDD)
Baseline characteristics by cohort
| Measure |
Placebo S1
n=98 Participants
Received placebo in Stage 1
|
ALKS 5461 2mg/2mg S1
n=24 Participants
Received ALKS 5461 2mg/2mg in Stage 1
|
ALKS 5461 8mg/8mg S1
n=19 Participants
Received ALKS 5461 8mg/8mg in Stage 1
|
Total
n=141 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
46.6 years
STANDARD_DEVIATION 11.0 • n=5 Participants
|
45.2 years
STANDARD_DEVIATION 10.9 • n=7 Participants
|
45.8 years
STANDARD_DEVIATION 11.9 • n=5 Participants
|
46.3 years
STANDARD_DEVIATION 11.1 • n=4 Participants
|
|
Sex: Female, Male
Female
|
68 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
96 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
45 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
23 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
74 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
102 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
98 Count of participants
n=5 Participants
|
24 Count of participants
n=7 Participants
|
19 Count of participants
n=5 Participants
|
141 Count of participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline and 4 weeks for each stagePopulation: Stage 1 and Stage 2 Full Analysis Sets (FAS) consisted of subjects who were randomized and took at least 1 dose of study drug and had at least 1 postbaseline HAM-D17 assessment in the respective stage. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 8/8 group for efficacy analysis.
The HAM-D17 scale is a clinician-administered questionnaire comprised of 17 items used to measure the severity of MDD symptoms. Scores range from 0 (no apparent symptoms) to 50 (most severe symptoms). Individual questionnaire items include depressed mood, work and activities, insomnia (early), insomnia (middle), insomnia (late), genital symptoms, somatic symptoms (gastrointestinal), loss of weight, somatic symptoms (general), feelings of guilt, suicide, anxiety (psychic), anxiety (somatic), hypochondriasis, insight, agitation, and retardation.
Outcome measures
| Measure |
Placebo S1
n=95 Participants
Subjects randomized to placebo in Stage 1
|
ALKS 5461 2mg/2mg S1
n=20 Participants
Subjects randomized to ALKS 5461 2mg/2mg in Stage 1
|
ALKS 5461 8mg/8mg S1
n=20 Participants
Subjects randomized to ALKS 5461 8mg/8mg in Stage 1
|
Placebo S2
n=20 Participants
Subjects randomized to placebo in Stage 2
|
ALKS 5461 2mg/2mg S2
n=23 Participants
Subjects randomized to ALKS 5461 2mg/2mg in Stage 2
|
ALKS 5461 8mg/8mg S2
n=22 Participants
Subjects randomized to ALKS 5461 8mg/8mg in Stage 2
|
|---|---|---|---|---|---|---|
|
Change From Baseline to Week 4 in Hamilton Rating Scale for Depression (HAM-D17) Total Score
|
-7.1 score on a scale
Standard Error 0.6
|
-9.3 score on a scale
Standard Error 1.5
|
-6.6 score on a scale
Standard Error 1.6
|
-1.5 score on a scale
Standard Error 1.1
|
-5.2 score on a scale
Standard Error 1.2
|
-3.3 score on a scale
Standard Error 1.1
|
SECONDARY outcome
Timeframe: 4 weeks for each stagePopulation: Stage 1 and Stage 2 Full Analysis Sets (FAS) consisted of subjects who were randomized and took at least 1 dose of study drug and had at least 1 postbaseline HAM-D17 assessment in the respective stage.
The proportion of subjects demonstrating HAM-D17 treatment response, defined as a ≥ 50% reduction in HAM-D17 score from baseline to the end of the efficacy period (Week 4). The HAM-D17 is a clinician administered questionnaire comprised of 17 questions used to assess the severity of a patient's depression. Scores range from 0 (no apparent symptoms) to 50 (most severe symptoms). Individual questionnaire items include depressed mood, work and activities, insomnia (early), insomnia (middle), insomnia (late), genital symptoms, somatic symptoms (gastrointestinal), loss of weight, somatic symptoms (general), feelings of guilt, suicide, anxiety (psychic), anxiety (somatic), hypochondriasis, insight, agitation, and retardation.
Outcome measures
| Measure |
Placebo S1
n=90 Participants
Subjects randomized to placebo in Stage 1
|
ALKS 5461 2mg/2mg S1
n=17 Participants
Subjects randomized to ALKS 5461 2mg/2mg in Stage 1
|
ALKS 5461 8mg/8mg S1
n=14 Participants
Subjects randomized to ALKS 5461 8mg/8mg in Stage 1
|
Placebo S2
n=20 Participants
Subjects randomized to placebo in Stage 2
|
ALKS 5461 2mg/2mg S2
n=18 Participants
Subjects randomized to ALKS 5461 2mg/2mg in Stage 2
|
ALKS 5461 8mg/8mg S2
n=18 Participants
Subjects randomized to ALKS 5461 8mg/8mg in Stage 2
|
|---|---|---|---|---|---|---|
|
Proportion of Patients Who Exhibited Treatment Response (HAM-D17)
Yes
|
23 Participants
|
8 Participants
|
5 Participants
|
3 Participants
|
6 Participants
|
5 Participants
|
|
Proportion of Patients Who Exhibited Treatment Response (HAM-D17)
No
|
67 Participants
|
9 Participants
|
9 Participants
|
17 Participants
|
12 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: 4 weeks for each stagePopulation: Stage 1 and Stage 2 Full Analysis Sets (FAS) consisted of subjects who were randomized and took at least 1 dose of study drug and had at least 1 postbaseline HAM-D17 assessment in the respective stage. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 8/8 group for efficacy analysis.
The MADRS-10 scale is a clinician-administered questionnaire comprised of 10 items used to measure the severity of MDD symptoms. Scores range from 0 (no apparent symptoms) to 60 (most severe symptoms). Individual questionnaire items include: Apparent Sadness, Reported Sadness, Inner Tension, Reduced Sleep, Reduced Appetite, Concentration Difficulties, Lassitude, Inability to Feel, Pessimistic Thoughts, and Suicidal Thoughts.
Outcome measures
| Measure |
Placebo S1
n=95 Participants
Subjects randomized to placebo in Stage 1
|
ALKS 5461 2mg/2mg S1
n=20 Participants
Subjects randomized to ALKS 5461 2mg/2mg in Stage 1
|
ALKS 5461 8mg/8mg S1
n=20 Participants
Subjects randomized to ALKS 5461 8mg/8mg in Stage 1
|
Placebo S2
n=20 Participants
Subjects randomized to placebo in Stage 2
|
ALKS 5461 2mg/2mg S2
n=23 Participants
Subjects randomized to ALKS 5461 2mg/2mg in Stage 2
|
ALKS 5461 8mg/8mg S2
n=22 Participants
Subjects randomized to ALKS 5461 8mg/8mg in Stage 2
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Montgomery Asberg Depression Rating Scale (MADRS) Total Score
|
-9.6 score on a scale
Standard Error 0.9
|
-13.3 score on a scale
Standard Error 2.2
|
-11.3 score on a scale
Standard Error 2.3
|
-2.1 score on a scale
Standard Error 1.6
|
-8.8 score on a scale
Standard Error 1.7
|
-4.7 score on a scale
Standard Error 1.7
|
SECONDARY outcome
Timeframe: 4 weeks for each stagePopulation: Stage 1 and Stage 2 Full Analysis Sets (FAS) consisted of subjects who were randomized and took at least 1 dose of study drug and had at least 1 postbaseline HAM-D17 assessment in the respective stage. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 8/8 group for efficacy analysis.
The CGI-S is a 7-point scale that requires the clinician to assess how mentally ill the patient is at a specific point in time. Based on the scale, patients are categorized as follows: "1: normal, not at all ill"; "2: borderline mentally ill"; "3: mildly ill"; "4: moderately ill"; "5: markedly ill"; "6: severely ill"; and "7: among the most extremely ill patients."
Outcome measures
| Measure |
Placebo S1
n=95 Participants
Subjects randomized to placebo in Stage 1
|
ALKS 5461 2mg/2mg S1
n=20 Participants
Subjects randomized to ALKS 5461 2mg/2mg in Stage 1
|
ALKS 5461 8mg/8mg S1
n=20 Participants
Subjects randomized to ALKS 5461 8mg/8mg in Stage 1
|
Placebo S2
n=20 Participants
Subjects randomized to placebo in Stage 2
|
ALKS 5461 2mg/2mg S2
n=23 Participants
Subjects randomized to ALKS 5461 2mg/2mg in Stage 2
|
ALKS 5461 8mg/8mg S2
n=22 Participants
Subjects randomized to ALKS 5461 8mg/8mg in Stage 2
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Clinical Global Impression - Severity (CGI-S) Total Score
|
-1.0 score on a scale
Standard Error 0.1
|
-1.3 score on a scale
Standard Error 0.2
|
-1.2 score on a scale
Standard Error 0.3
|
-0.5 score on a scale
Standard Error 0.2
|
-1.1 score on a scale
Standard Error 0.2
|
-0.6 score on a scale
Standard Error 0.2
|
Adverse Events
Placebo S1
Serious events: 1 serious events
Other events: 42 other events
Deaths: 0 deaths
ALKS 5461 2mg/2mg S1
Serious events: 1 serious events
Other events: 15 other events
Deaths: 0 deaths
ALKS 5461 8mg/8mg S1
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Placebo S2
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
ALKS 5461 2mg/2mg S2
Serious events: 1 serious events
Other events: 19 other events
Deaths: 0 deaths
ALKS 5461 8mg/8mg S2
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo S1
n=98 participants at risk
Received placebo in Stage 1
|
ALKS 5461 2mg/2mg S1
n=24 participants at risk
Received ALKS 5461 2mg/2mg in Stage 1
|
ALKS 5461 8mg/8mg S1
n=19 participants at risk
Received ALKS 5461 8mg/8mg in Stage 1
|
Placebo S2
n=20 participants at risk
Received placebo in Stage 2
|
ALKS 5461 2mg/2mg S2
n=23 participants at risk
Received ALKS 5461 2mg/2mg in Stage 1
|
ALKS 5461 8mg/8mg S2
n=22 participants at risk
Received ALKS 5461 8mg/8mg in Stage 1
|
|---|---|---|---|---|---|---|
|
Psychiatric disorders
Multiple drug overdose intentional
|
1.0%
1/98 • Number of events 1 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
0.00%
0/24 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
0.00%
0/19 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
0.00%
0/20 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
0.00%
0/23 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
0.00%
0/22 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
|
Psychiatric disorders
Drug withdrawal syndrome
|
0.00%
0/98 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
4.2%
1/24 • Number of events 1 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
0.00%
0/19 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
0.00%
0/20 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
0.00%
0/23 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
0.00%
0/22 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intraocular melanoma
|
0.00%
0/98 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
0.00%
0/24 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
0.00%
0/19 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
0.00%
0/20 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
4.3%
1/23 • Number of events 1 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
0.00%
0/22 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
Other adverse events
| Measure |
Placebo S1
n=98 participants at risk
Received placebo in Stage 1
|
ALKS 5461 2mg/2mg S1
n=24 participants at risk
Received ALKS 5461 2mg/2mg in Stage 1
|
ALKS 5461 8mg/8mg S1
n=19 participants at risk
Received ALKS 5461 8mg/8mg in Stage 1
|
Placebo S2
n=20 participants at risk
Received placebo in Stage 2
|
ALKS 5461 2mg/2mg S2
n=23 participants at risk
Received ALKS 5461 2mg/2mg in Stage 1
|
ALKS 5461 8mg/8mg S2
n=22 participants at risk
Received ALKS 5461 8mg/8mg in Stage 1
|
|---|---|---|---|---|---|---|
|
Eye disorders
Dry eye
|
0.00%
0/98 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
0.00%
0/24 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
5.3%
1/19 • Number of events 1 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
0.00%
0/20 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
0.00%
0/23 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
0.00%
0/22 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
|
Eye disorders
Miosis
|
0.00%
0/98 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
0.00%
0/24 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
5.3%
1/19 • Number of events 1 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
0.00%
0/20 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
0.00%
0/23 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
0.00%
0/22 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
|
Eye disorders
Vision blurred
|
0.00%
0/98 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
0.00%
0/24 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
5.3%
1/19 • Number of events 1 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
0.00%
0/20 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
4.3%
1/23 • Number of events 1 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
0.00%
0/22 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
|
Gastrointestinal disorders
Nausea
|
6.1%
6/98 • Number of events 7 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
20.8%
5/24 • Number of events 6 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
47.4%
9/19 • Number of events 10 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
10.0%
2/20 • Number of events 2 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
43.5%
10/23 • Number of events 11 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
22.7%
5/22 • Number of events 5 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
|
Gastrointestinal disorders
Constipation
|
5.1%
5/98 • Number of events 6 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
8.3%
2/24 • Number of events 2 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
5.3%
1/19 • Number of events 1 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
5.0%
1/20 • Number of events 1 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
8.7%
2/23 • Number of events 2 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
9.1%
2/22 • Number of events 2 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/98 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
12.5%
3/24 • Number of events 5 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
36.8%
7/19 • Number of events 7 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
5.0%
1/20 • Number of events 1 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
21.7%
5/23 • Number of events 6 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
9.1%
2/22 • Number of events 2 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
|
Gastrointestinal disorders
Dry mouth
|
6.1%
6/98 • Number of events 6 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
8.3%
2/24 • Number of events 2 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
10.5%
2/19 • Number of events 2 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
10.0%
2/20 • Number of events 2 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
8.7%
2/23 • Number of events 2 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
4.5%
1/22 • Number of events 1 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
|
Gastrointestinal disorders
Dyspepsia
|
4.1%
4/98 • Number of events 4 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
0.00%
0/24 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
10.5%
2/19 • Number of events 2 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
0.00%
0/20 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
4.3%
1/23 • Number of events 1 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
0.00%
0/22 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/98 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
4.2%
1/24 • Number of events 1 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
5.3%
1/19 • Number of events 1 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
0.00%
0/20 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
4.3%
1/23 • Number of events 1 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
4.5%
1/22 • Number of events 1 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.0%
1/98 • Number of events 1 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
0.00%
0/24 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
0.00%
0/19 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
5.0%
1/20 • Number of events 1 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
13.0%
3/23 • Number of events 3 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
4.5%
1/22 • Number of events 1 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
0.00%
0/98 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
0.00%
0/24 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
5.3%
1/19 • Number of events 1 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
0.00%
0/20 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
0.00%
0/23 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
4.5%
1/22 • Number of events 1 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
|
Gastrointestinal disorders
Diarrhoea
|
5.1%
5/98 • Number of events 6 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
4.2%
1/24 • Number of events 1 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
0.00%
0/19 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
10.0%
2/20 • Number of events 2 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
4.3%
1/23 • Number of events 1 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
0.00%
0/22 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
|
General disorders
Fatigue
|
4.1%
4/98 • Number of events 4 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
8.3%
2/24 • Number of events 2 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
5.3%
1/19 • Number of events 1 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
5.0%
1/20 • Number of events 1 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
8.7%
2/23 • Number of events 2 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
4.5%
1/22 • Number of events 1 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
|
General disorders
Feeling abnormal
|
0.00%
0/98 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
0.00%
0/24 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
5.3%
1/19 • Number of events 1 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
0.00%
0/20 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
0.00%
0/23 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
0.00%
0/22 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
|
General disorders
Product taste abnormal
|
0.00%
0/98 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
0.00%
0/24 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
0.00%
0/19 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
0.00%
0/20 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
13.0%
3/23 • Number of events 3 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
9.1%
2/22 • Number of events 2 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/98 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
0.00%
0/24 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
5.3%
1/19 • Number of events 1 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
0.00%
0/20 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
0.00%
0/23 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
0.00%
0/22 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/98 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
4.2%
1/24 • Number of events 1 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
5.3%
1/19 • Number of events 1 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
0.00%
0/20 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
0.00%
0/23 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
0.00%
0/22 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
|
Infections and infestations
Nasopharyngitis
|
2.0%
2/98 • Number of events 2 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
0.00%
0/24 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
0.00%
0/19 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
5.0%
1/20 • Number of events 1 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
0.00%
0/23 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
0.00%
0/22 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
|
Injury, poisoning and procedural complications
Poisoning
|
0.00%
0/98 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
0.00%
0/24 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
5.3%
1/19 • Number of events 1 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
0.00%
0/20 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
0.00%
0/23 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
0.00%
0/22 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
|
Investigations
Blood pressure increased
|
0.00%
0/98 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
4.2%
1/24 • Number of events 1 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
5.3%
1/19 • Number of events 1 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
0.00%
0/20 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
0.00%
0/23 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
0.00%
0/22 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
|
Investigations
Blood thyroid stimulating hormone increased
|
0.00%
0/98 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
0.00%
0/24 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
5.3%
1/19 • Number of events 1 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
0.00%
0/20 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
0.00%
0/23 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
0.00%
0/22 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
|
Investigations
Electrocardiogram RR interval prolonged
|
0.00%
0/98 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
0.00%
0/24 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
5.3%
1/19 • Number of events 1 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
0.00%
0/20 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
0.00%
0/23 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
0.00%
0/22 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
|
Investigations
Weight increased
|
1.0%
1/98 • Number of events 1 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
0.00%
0/24 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
5.3%
1/19 • Number of events 1 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
0.00%
0/20 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
0.00%
0/23 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
0.00%
0/22 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
1.0%
1/98 • Number of events 1 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
0.00%
0/24 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
5.3%
1/19 • Number of events 1 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
0.00%
0/20 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
0.00%
0/23 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
0.00%
0/22 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/98 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
0.00%
0/24 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
10.5%
2/19 • Number of events 2 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
0.00%
0/20 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
0.00%
0/23 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
0.00%
0/22 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.0%
1/98 • Number of events 1 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
0.00%
0/24 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
5.3%
1/19 • Number of events 2 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
0.00%
0/20 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
0.00%
0/23 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
0.00%
0/22 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
0.00%
0/98 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
0.00%
0/24 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
0.00%
0/19 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
0.00%
0/20 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
8.7%
2/23 • Number of events 2 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
0.00%
0/22 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
|
Nervous system disorders
Dizziness
|
5.1%
5/98 • Number of events 5 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
16.7%
4/24 • Number of events 5 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
47.4%
9/19 • Number of events 10 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
5.0%
1/20 • Number of events 1 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
21.7%
5/23 • Number of events 5 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
18.2%
4/22 • Number of events 4 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
|
Nervous system disorders
Headache
|
14.3%
14/98 • Number of events 19 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
4.2%
1/24 • Number of events 1 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
26.3%
5/19 • Number of events 8 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
20.0%
4/20 • Number of events 5 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
4.3%
1/23 • Number of events 2 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
22.7%
5/22 • Number of events 8 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
|
Nervous system disorders
Sedation
|
2.0%
2/98 • Number of events 2 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
12.5%
3/24 • Number of events 4 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
26.3%
5/19 • Number of events 5 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
0.00%
0/20 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
17.4%
4/23 • Number of events 5 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
4.5%
1/22 • Number of events 1 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/98 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
0.00%
0/24 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
15.8%
3/19 • Number of events 3 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
0.00%
0/20 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
4.3%
1/23 • Number of events 1 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
9.1%
2/22 • Number of events 2 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/98 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
0.00%
0/24 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
10.5%
2/19 • Number of events 2 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
0.00%
0/20 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
0.00%
0/23 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
0.00%
0/22 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
|
Nervous system disorders
Somnolence
|
2.0%
2/98 • Number of events 2 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
0.00%
0/24 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
10.5%
2/19 • Number of events 2 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
0.00%
0/20 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
8.7%
2/23 • Number of events 2 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
9.1%
2/22 • Number of events 3 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/98 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
0.00%
0/24 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
5.3%
1/19 • Number of events 1 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
0.00%
0/20 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
0.00%
0/23 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
0.00%
0/22 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
|
Psychiatric disorders
Anxiety
|
1.0%
1/98 • Number of events 1 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
0.00%
0/24 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
5.3%
1/19 • Number of events 1 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
5.0%
1/20 • Number of events 1 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
4.3%
1/23 • Number of events 1 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
0.00%
0/22 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
|
Psychiatric disorders
Suicidal ideation
|
1.0%
1/98 • Number of events 3 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
0.00%
0/24 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
5.3%
1/19 • Number of events 1 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
0.00%
0/20 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
0.00%
0/23 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
0.00%
0/22 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
|
Psychiatric disorders
Euphoric mood
|
0.00%
0/98 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
8.3%
2/24 • Number of events 2 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
0.00%
0/19 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
0.00%
0/20 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
0.00%
0/23 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
0.00%
0/22 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
3.1%
3/98 • Number of events 3 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
0.00%
0/24 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
5.3%
1/19 • Number of events 1 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
0.00%
0/20 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
17.4%
4/23 • Number of events 4 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
4.5%
1/22 • Number of events 1 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/98 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
0.00%
0/24 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
5.3%
1/19 • Number of events 1 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
0.00%
0/20 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
0.00%
0/23 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
0.00%
0/22 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/98 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
0.00%
0/24 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
5.3%
1/19 • Number of events 1 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
0.00%
0/20 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
0.00%
0/23 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
4.5%
1/22 • Number of events 1 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/98 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
0.00%
0/24 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
5.3%
1/19 • Number of events 1 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
0.00%
0/20 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
0.00%
0/23 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
0.00%
0/22 • 4 weeks for each stage
The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Should an Investigator desire to disclose study results, Sponsor will review the results disclosure prior to public release and can embargo the disclosure for a period of at least 60 days. Revisions to the disclosure will be negotiated in good faith. For a multicenter study the Investigators agree to publish/publicly present the results together with the other sites for the 12 month period after study results are available unless Sponsor grants written permission in advance.
- Publication restrictions are in place
Restriction type: OTHER