Trial Outcomes & Findings for Brexpiprazole as Adjunctive Therapy With Major Depressive Disorder and an Inadequate Response to Previous Adjunctive Therapy (NCT NCT02012218)
NCT ID: NCT02012218
Last Updated: 2015-12-29
Results Overview
The MADRS was used as the primary efficacy assessment of level of depression. The MADRS was administered using the Structured Interview Guide for the MADRS. Detailed instructions were provided.The MADRS consists of 10 items each, with 7 defined grades of severity (ie, 0 to 6, with 0 being the "best" rating and 6 being the "worst" rating). The MADRS total score is the sum of ratings for all 10 items; therefore, possible total scores range from 0 to 60. The MADRS total score least squares (LS) mean changes from baseline to Week 6 is mentioned below.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
61 participants
Primary outcome timeframe
Baseline and Week 6
Results posted on
2015-12-29
Participant Flow
This trial was conducted in 61 participants in 28 trial sites, all of which were located in the United States.
The trial consisted of a continuous 6-week open-label treatment period including an initial 2-week titration period with a 30-day (+2 days) follow-up period.
Participant milestones
| Measure |
Group 1A
Participants who had received a prescribed number of tablets of aripiprazole (baseline/primary antidepressant therapy \[ADT\]) and adjunctive therapy were switched to ADT plus one tablet of brexpiprazole as adjunctive therapy daily throughout the 6-week treatment period.
|
Group 1B
Participants who had received a prescribed number of tablets of quetiapine IR (immediate release) or XR (extended release) (baseline/primary ADT) and adjunctive therapy were switched to ADT plus one tablet of brexpiprazole as adjunctive therapy daily throughout the 6-week treatment period.
|
Group 2
Participants who had received a prescribed number of tablets of any Selective Serotonin Reuptake Inhibitors (SSRI), any Serotonin-norepinephrine Reuptake Inhibitors (SNRI), any tricyclic antidepressant, or Oleptro (trazodone hydrochloride) IR or XR (baseline/primary ADT) and adjunctive therapy were switched to ADT plus one tablet of brexpiprazole as adjunctive therapy daily throughout the 6-week treatment period.
|
Group 3
Participants who had received a prescribed number of tablets of bupropion (baseline/primary ADT) and adjunctive therapy were switched to ADT plus one tablet of brexpiprazole as adjunctive therapy daily throughout the 6-week treatment period.
|
Group 4
Participants who had received a prescribed number of tablets of stimulants such as modafinil, methylphenidate, or psychostimulant (baseline/primary ADT) and adjunctive therapy were switched to ADT plus one tablet of brexpiprazole as adjunctive therapy daily throughout the 6-week treatment period.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
12
|
11
|
13
|
19
|
6
|
|
Overall Study
COMPLETED
|
8
|
10
|
11
|
17
|
5
|
|
Overall Study
NOT COMPLETED
|
4
|
1
|
2
|
2
|
1
|
Reasons for withdrawal
| Measure |
Group 1A
Participants who had received a prescribed number of tablets of aripiprazole (baseline/primary antidepressant therapy \[ADT\]) and adjunctive therapy were switched to ADT plus one tablet of brexpiprazole as adjunctive therapy daily throughout the 6-week treatment period.
|
Group 1B
Participants who had received a prescribed number of tablets of quetiapine IR (immediate release) or XR (extended release) (baseline/primary ADT) and adjunctive therapy were switched to ADT plus one tablet of brexpiprazole as adjunctive therapy daily throughout the 6-week treatment period.
|
Group 2
Participants who had received a prescribed number of tablets of any Selective Serotonin Reuptake Inhibitors (SSRI), any Serotonin-norepinephrine Reuptake Inhibitors (SNRI), any tricyclic antidepressant, or Oleptro (trazodone hydrochloride) IR or XR (baseline/primary ADT) and adjunctive therapy were switched to ADT plus one tablet of brexpiprazole as adjunctive therapy daily throughout the 6-week treatment period.
|
Group 3
Participants who had received a prescribed number of tablets of bupropion (baseline/primary ADT) and adjunctive therapy were switched to ADT plus one tablet of brexpiprazole as adjunctive therapy daily throughout the 6-week treatment period.
|
Group 4
Participants who had received a prescribed number of tablets of stimulants such as modafinil, methylphenidate, or psychostimulant (baseline/primary ADT) and adjunctive therapy were switched to ADT plus one tablet of brexpiprazole as adjunctive therapy daily throughout the 6-week treatment period.
|
|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
1
|
1
|
1
|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
1
|
0
|
0
|
|
Overall Study
Protocol Specified
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Protocol Deviation
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Brexpiprazole as Adjunctive Therapy With Major Depressive Disorder and an Inadequate Response to Previous Adjunctive Therapy
Baseline characteristics by cohort
| Measure |
Group 1A
n=12 Participants
Participants who had received a prescribed number of tablets of aripiprazole (baseline/primary antidepressant therapy \[ADT\]) and adjunctive therapy were switched to ADT plus one tablet of brexpiprazole as adjunctive therapy daily throughout the 6-week treatment period.
|
Group 1B
n=11 Participants
Participants who had received a prescribed number of tablets of quetiapine IR (immediate release) or XR (extended release) (baseline/primary ADT) and adjunctive therapy were switched to ADT plus one tablet of brexpiprazole as adjunctive therapy daily throughout the 6-week treatment period.
|
Group 2
n=13 Participants
Participants who had received a prescribed number of tablets of any Selective Serotonin Reuptake Inhibitors (SSRI), any Serotonin-norepinephrine Reuptake Inhibitors (SNRI), any tricyclic antidepressant, or Oleptro (trazodone hydrochloride) IR or XR (baseline/primary ADT) and adjunctive therapy were switched to ADT plus one tablet of brexpiprazole as adjunctive therapy daily throughout the 6-week treatment period.
|
Group 3
n=19 Participants
Participants who had received a prescribed number of tablets of bupropion (baseline/primary ADT) and adjunctive therapy were switched to ADT plus one tablet of brexpiprazole as adjunctive therapy daily throughout the 6-week treatment period.
|
Group 4
n=6 Participants
Participants who had received a prescribed number of tablets of stimulants such as modafinil, methylphenidate, or psychostimulant (baseline/primary ADT) and adjunctive therapy were switched to ADT plus one tablet of brexpiprazole as adjunctive therapy daily throughout the 6-week treatment period.
|
Total
n=61 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
50.2 Years
STANDARD_DEVIATION 8.13 • n=5 Participants
|
41.8 Years
STANDARD_DEVIATION 13.57 • n=7 Participants
|
48.5 Years
STANDARD_DEVIATION 12.20 • n=5 Participants
|
44.1 Years
STANDARD_DEVIATION 13.64 • n=4 Participants
|
41.7 Years
STANDARD_DEVIATION 13.59 • n=21 Participants
|
45.6 Years
STANDARD_DEVIATION 12.44 • n=8 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
43 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
18 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 6Population: All participants who took at least one dose of brexpiprazole and who had a valid baseline assessment and at least one valid post-baseline efficacy assessment.
The MADRS was used as the primary efficacy assessment of level of depression. The MADRS was administered using the Structured Interview Guide for the MADRS. Detailed instructions were provided.The MADRS consists of 10 items each, with 7 defined grades of severity (ie, 0 to 6, with 0 being the "best" rating and 6 being the "worst" rating). The MADRS total score is the sum of ratings for all 10 items; therefore, possible total scores range from 0 to 60. The MADRS total score least squares (LS) mean changes from baseline to Week 6 is mentioned below.
Outcome measures
| Measure |
Group 1A
n=12 Participants
Participants who had received a prescribed number of tablets of aripiprazole (baseline/primary antidepressant therapy \[ADT\]) and adjunctive therapy were switched to ADT plus one tablet of brexpiprazole as adjunctive therapy daily throughout the 6-week treatment period.
|
Group 1B
n=10 Participants
Participants who had received a prescribed number of tablets of quetiapine IR (immediate release) or XR (extended release) (baseline/primary ADT) and adjunctive therapy were switched to ADT plus one tablet of brexpiprazole as adjunctive therapy daily throughout the 6-week treatment period.
|
Group 2
n=12 Participants
Participants who had received a prescribed number of tablets of any Selective Serotonin Reuptake Inhibitors (SSRI), any Serotonin-norepinephrine Reuptake Inhibitors (SNRI), any tricyclic antidepressant, or Oleptro (trazodone hydrochloride) IR or XR (baseline/primary ADT) and adjunctive therapy were switched to ADT plus one tablet of brexpiprazole as adjunctive therapy daily throughout the 6-week treatment period.
|
Group 3
n=19 Participants
Participants who had received a prescribed number of tablets of bupropion (baseline/primary ADT) and adjunctive therapy were switched to ADT plus one tablet of brexpiprazole as adjunctive therapy daily throughout the 6-week treatment period.
|
Group 4
n=6 Participants
Participants who had received a prescribed number of tablets of stimulants such as modafinil, methylphenidate, or psychostimulant (baseline/primary ADT) and adjunctive therapy were switched to ADT plus one tablet of brexpiprazole as adjunctive therapy daily throughout the 6-week treatment period.
|
|---|---|---|---|---|---|
|
Mean Change From Baseline to Week 6 in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
|
-12.8 Units on a scale
Standard Error 2.26
|
-18.4 Units on a scale
Standard Error 2.10
|
-19.5 Units on a scale
Standard Error 1.99
|
-19.2 Units on a scale
Standard Error 1.59
|
-16.8 Units on a scale
Standard Error 2.97
|
Adverse Events
Group 1A
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Group 1B
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Group 2
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Group 3
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Group 4
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1A
n=12 participants at risk
Participants who had received a prescribed number of tablets of aripiprazole (baseline/primary antidepressant therapy \[ADT\]) and adjunctive therapy were switched to ADT plus one tablet of brexpiprazole as adjunctive therapy daily throughout the 6-week treatment period.
|
Group 1B
n=11 participants at risk
Participants who had received a prescribed number of tablets of quetiapine IR (immediate release) or XR (extended release) (baseline/primary ADT) and adjunctive therapy were switched to ADT plus one tablet of brexpiprazole as adjunctive therapy daily throughout the 6-week treatment period.
|
Group 2
n=13 participants at risk
Participants who had received a prescribed number of tablets of any Selective Serotonin Reuptake Inhibitors (SSRI), any Serotonin-norepinephrine Reuptake Inhibitors (SNRI), any tricyclic antidepressant, or Oleptro (trazodone hydrochloride) IR or XR (baseline/primary ADT) and adjunctive therapy were switched to ADT plus one tablet of brexpiprazole as adjunctive therapy daily throughout the 6-week treatment period.
|
Group 3
n=19 participants at risk
Participants who had received a prescribed number of tablets of bupropion (baseline/primary ADT) and adjunctive therapy were switched to ADT plus one tablet of brexpiprazole as adjunctive therapy daily throughout the 6-week treatment period.
|
Group 4
n=6 participants at risk
Participants who had received a prescribed number of tablets of stimulants such as modafinil, methylphenidate, or psychostimulant (baseline/primary ADT) and adjunctive therapy were switched to ADT plus one tablet of brexpiprazole as adjunctive therapy daily throughout the 6-week treatment period.
|
|---|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/12 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
9.1%
1/11 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/13 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/19 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/6 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
Other adverse events
| Measure |
Group 1A
n=12 participants at risk
Participants who had received a prescribed number of tablets of aripiprazole (baseline/primary antidepressant therapy \[ADT\]) and adjunctive therapy were switched to ADT plus one tablet of brexpiprazole as adjunctive therapy daily throughout the 6-week treatment period.
|
Group 1B
n=11 participants at risk
Participants who had received a prescribed number of tablets of quetiapine IR (immediate release) or XR (extended release) (baseline/primary ADT) and adjunctive therapy were switched to ADT plus one tablet of brexpiprazole as adjunctive therapy daily throughout the 6-week treatment period.
|
Group 2
n=13 participants at risk
Participants who had received a prescribed number of tablets of any Selective Serotonin Reuptake Inhibitors (SSRI), any Serotonin-norepinephrine Reuptake Inhibitors (SNRI), any tricyclic antidepressant, or Oleptro (trazodone hydrochloride) IR or XR (baseline/primary ADT) and adjunctive therapy were switched to ADT plus one tablet of brexpiprazole as adjunctive therapy daily throughout the 6-week treatment period.
|
Group 3
n=19 participants at risk
Participants who had received a prescribed number of tablets of bupropion (baseline/primary ADT) and adjunctive therapy were switched to ADT plus one tablet of brexpiprazole as adjunctive therapy daily throughout the 6-week treatment period.
|
Group 4
n=6 participants at risk
Participants who had received a prescribed number of tablets of stimulants such as modafinil, methylphenidate, or psychostimulant (baseline/primary ADT) and adjunctive therapy were switched to ADT plus one tablet of brexpiprazole as adjunctive therapy daily throughout the 6-week treatment period.
|
|---|---|---|---|---|---|
|
Nervous system disorders
Akathisia
|
16.7%
2/12 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/11 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/13 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
15.8%
3/19 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/6 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
|
Nervous system disorders
Headache
|
8.3%
1/12 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
9.1%
1/11 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
7.7%
1/13 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
5.3%
1/19 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
16.7%
1/6 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/12 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/11 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
7.7%
1/13 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
10.5%
2/19 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
16.7%
1/6 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/12 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/11 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
15.4%
2/13 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/19 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/6 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
|
Nervous system disorders
Poor quality sleep
|
0.00%
0/12 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
9.1%
1/11 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/13 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
5.3%
1/19 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/6 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
|
Nervous system disorders
Sedation
|
0.00%
0/12 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/11 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
7.7%
1/13 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/19 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
16.7%
1/6 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
|
Nervous system disorders
Tension headache
|
0.00%
0/12 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/11 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/13 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
10.5%
2/19 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/6 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
|
Nervous system disorders
Aphasia
|
0.00%
0/12 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/11 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/13 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
5.3%
1/19 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/6 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/12 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/11 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/13 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
5.3%
1/19 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/6 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/12 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/11 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/13 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
5.3%
1/19 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/6 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
|
Nervous system disorders
Extrapyramidal disorder
|
8.3%
1/12 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/11 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/13 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/19 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/6 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
|
Nervous system disorders
Glabellar reflex abnormal
|
0.00%
0/12 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/11 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
7.7%
1/13 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/19 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/6 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/12 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/11 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/13 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
5.3%
1/19 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/6 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/12 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/11 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/13 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
5.3%
1/19 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/6 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/12 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
9.1%
1/11 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
15.4%
2/13 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
10.5%
2/19 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/6 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/12 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
9.1%
1/11 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
15.4%
2/13 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
5.3%
1/19 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/6 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
|
Psychiatric disorders
Anxiety
|
8.3%
1/12 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
9.1%
1/11 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/13 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/19 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/6 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
|
Psychiatric disorders
Initial insomnia
|
0.00%
0/12 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
9.1%
1/11 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/13 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/19 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
16.7%
1/6 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/12 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/11 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/13 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
5.3%
1/19 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/6 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
|
Psychiatric disorders
Depressive symptom
|
0.00%
0/12 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/11 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
7.7%
1/13 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/19 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/6 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
|
Psychiatric disorders
Disinhibition
|
0.00%
0/12 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/11 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/13 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
5.3%
1/19 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/6 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
|
Psychiatric disorders
Distractibility
|
0.00%
0/12 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/11 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/13 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
5.3%
1/19 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/6 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
|
Psychiatric disorders
Middle insomnia
|
0.00%
0/12 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/11 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/13 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
5.3%
1/19 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/6 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
|
Gastrointestinal disorders
Dry mouth
|
16.7%
2/12 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/11 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
7.7%
1/13 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
10.5%
2/19 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/6 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/12 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/11 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
7.7%
1/13 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
15.8%
3/19 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/6 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/12 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/11 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/13 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/19 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
16.7%
1/6 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/12 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/11 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/13 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
5.3%
1/19 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/6 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/12 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/11 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
7.7%
1/13 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/19 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/6 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/12 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/11 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/13 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
5.3%
1/19 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/6 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
|
General disorders
Fatigue
|
8.3%
1/12 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/11 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
15.4%
2/13 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
15.8%
3/19 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
50.0%
3/6 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
|
Metabolism and nutrition disorders
Increased appetite
|
8.3%
1/12 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
9.1%
1/11 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
7.7%
1/13 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
10.5%
2/19 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/6 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
0.00%
0/12 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/11 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/13 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
5.3%
1/19 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/6 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
|
Metabolism and nutrition disorders
Food craving
|
0.00%
0/12 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/11 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
7.7%
1/13 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/19 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/6 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
|
Infections and infestations
Upper respiratory tract infection
|
8.3%
1/12 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
9.1%
1/11 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/13 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
5.3%
1/19 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/6 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/12 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/11 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/13 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/19 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
16.7%
1/6 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/12 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
9.1%
1/11 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/13 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/19 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/6 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
|
Infections and infestations
Viral infection
|
0.00%
0/12 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
9.1%
1/11 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/13 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/19 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/6 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.3%
1/12 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/11 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/13 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/19 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/6 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
|
Musculoskeletal and connective tissue disorders
Muscle rigidity
|
0.00%
0/12 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/11 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/13 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
5.3%
1/19 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/6 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
8.3%
1/12 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/11 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/13 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/19 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/6 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/12 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
9.1%
1/11 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/13 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/19 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/6 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/12 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/11 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/13 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
5.3%
1/19 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/6 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
|
Respiratory, thoracic and mediastinal disorders
Increased upper airway secretion
|
0.00%
0/12 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/11 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/13 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
5.3%
1/19 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/6 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
8.3%
1/12 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/11 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/13 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/19 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/6 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
|
Respiratory, thoracic and mediastinal disorders
Yawning
|
0.00%
0/12 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/11 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/13 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
5.3%
1/19 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/6 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
|
Investigations
Weight increased
|
0.00%
0/12 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
9.1%
1/11 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/13 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
5.3%
1/19 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/6 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
|
Investigations
Weight decreased
|
0.00%
0/12 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/11 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
7.7%
1/13 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/19 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/6 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/12 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/11 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/13 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
5.3%
1/19 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/6 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/12 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
9.1%
1/11 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/13 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/19 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/6 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
|
Skin and subcutaneous tissue disorders
Intertrigo
|
0.00%
0/12 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/11 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
7.7%
1/13 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/19 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/6 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
|
Eye disorders
Vision blurred
|
8.3%
1/12 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/11 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/13 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
5.3%
1/19 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/6 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/12 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
9.1%
1/11 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/13 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/19 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/6 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/12 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
9.1%
1/11 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/13 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/19 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/6 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/12 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/11 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/13 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
5.3%
1/19 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/6 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.00%
0/12 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/11 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/13 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/19 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
16.7%
1/6 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/12 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/11 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/13 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
5.3%
1/19 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/6 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
|
Reproductive system and breast disorders
Menstrual disorder
|
0.00%
0/12 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/11 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/13 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
5.3%
1/19 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/6 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/12 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/11 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/13 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
0.00%
0/19 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
16.7%
1/6 • Adverse events were reported from the signing of the informed consent until the end of trial with a safety follow-up of 30 (+2 ) days.
|
Additional Information
Global Medical Affairs
Otsuka Pharmaceutical Development and Commercialization, Inc.
Phone: 800 562-3974
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place